Specimen analyzer and specimen analysis method

ABSTRACT

The specimen analyzer includes: an input unit which receives an input of subject attribute information; an analysis unit which performs measurement of a specimen collected from a subject, and which performs analysis of the specimen based on a measurement result and the subject attribute information received by the input unit; and a controller which causes the analysis unit to be incapable of analyzing the specimen unless the input of the subject attribute information is performed with the input uni.

BACKGROUND Field of Invention

The invention relates to a specimen analyzer and a specimen analysismethod.

Technical Background

An analysis apparatus intended to be used by a user with insufficientexpertise and test skills is desirably configured not only to beoperated simply while preventing mistakes and the like, but also toprovide analysis results not requiring expertise and judgment based onthe expertise. Also, it is known that a normal value range differsdepending on a subject attribute, and that the analysis results areevaluated by use of normal value range information corresponding to theattribute.

Japanese Patent Application Publication No. 2001-124781 discloses ananalysis apparatus which analyzes specimens with normal value rangesdifferent depending on attribute information of subjects. This analysisapparatus is configured such that when attribute information of asubject is inputted and then a specimen is measured, the analysisapparatus refers to a table based on the attribute information,evaluates the results, and displays the results by distinguishingwhether or not the results are within the normal value ranges.

If the attribute information of the subject is not inputted, however,the analysis apparatus in Japanese Patent Application Publication No.2001-124781 may output only analysis results and fail to outputevaluation results because the analysis apparatus does not evaluate theanalysis results. As a result, a user is required to have expertise inorder to evaluate the analysis results.

SUMMARY OF THE INVENTION

The invention is aimed at reliably evaluating analysis results even whena user does not have expertise.

Specimen analyzer (100) according to a first aspect of the inventionincludes: input unit (20) which receives an input of subject attributeinformation; analysis unit (10) which measures a specimen collected froma subject, and which analyzes the specimen on the basis of a measurementresult and of the subject attribute information received by input unit(20); and controller (30) which performs control of causing analysisunit (10) to be incapable of analyzing the specimen unless the subjectattribute information is inputted with the input unit (20).

As described above, specimen analyzer (100) according to the firstaspect includes controller (30) which performs control of causinganalysis unit (10) to be incapable of analyzing the specimen unless thesubject attribute information is inputted with the input unit (20).Analysis operations for the specimen are not performed until the subjectattribute information is inputted. Thus, it is possible to performanalysis operations for the specimen after the subject attributeinformation is actually inputted. As a result, it is possible to outputanalysis results based on the subject attribute information, enablingthe user to evaluate with certainty the analysis results even withoutexpertise. Here, the “subject attribute information” is informationindicating an attribute of e.g. a subject or a patient. The subjectattribute information is information indicating, for example, thesubject's age, age group, birth year, birth date, sex, height, weight,and whether or not the subject is pregnant.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that the subject attribute informationinclude information on age. It may be more preferable that theinformation on age include at least one of an age, an age group, a birthyear, and a birth date. Such a configuration makes it possible toprevent operations concerning the analysis of the specimen if theinformation on age is not inputted as the subject attribute informationin the condition in which the normal value range differs depending onthe age and the sex of the subject.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that controller (30) perform control ofcausing analysis unit (10) to be incapable of measuring the specimenunless the subject attribute information is inputted with the input unit(20). In such a configuration, since the specimen is not measured untilthe subject attribute information is inputted, analysis based on themeasurement results is not performed. Thus, it is possible to analyzethe specimen after the subject attribute information is more reliablyinputted.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that until the subject attributeinformation is inputted with input unit (20), controller (30) wait, foreach specimen, to proceed to a next process concerning the analysis ofspecimen. In such a configuration, it is possible to measure thespecimen after the subject attribute information is more reliablyinputted because the processing of specimen analyzer (100) cannotproceed, for each specimen, unless the subject attribute information isinputted with input unit (20).

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that the analyzer include display unit(131) which displays an instruction on how to perform a series ofoperations concerning the analysis of the specimen, controller (30)advance, with the series of operations performed in accordance with theinstruction of display unit (131), a process concerning the analysis ofthe specimen, and controller (30) wait to proceed to a next processuntil the subject attribute information is inputted. Such aconfiguration makes it possible for the user with insufficient knowledgeabout the operation procedures to perform operations in accordance withthe instruction of display unit (131), which facilitates the operationsof specimen analyzer (100). In addition, since the processing waits toproceed to the next process until the subject attribute information isinputted, the user can reliably input the subject attribute information.

In this case, it may be preferable that controller (30) perform controlof causing display unit (131) to display an instruction to input thesubject attribute information. Such a configuration allows the user toreliably input the subject attribute information with the help of thedisplay of display unit (131).

In above-described specimen analyzer (100) which includes display unit(131), it may be preferable that display unit (131) include a touchpanel configured to display input unit (20). Such a configuration makesit possible to simplify the analyzer configuration and to downsize theanalyzer compared to the case of providing input unit (20) and displayunit (131) separately.

In above-described specimen analyzer (100) which includes display unit(131), it may be preferable that controller (30) cause display unit(131) to display a screen to confirm whether or not the subjectattribute information is correct when the subject attribute informationis inputted. Such a configuration allows the user to reliably input thecorrect subject attribute information.

In above-described specimen analyzer (100) which includes display unit(131), it may be preferable that controller (30) perform control ofcausing display unit (131) to display an instruction for pre-treatmentof the specimen and time for the pre-treatment of the specimen, and thecontroller (30) wait to proceed to a next process concerning theanalysis of the specimen until the time for the pre-treatment elapses.Such a configuration makes it possible to reliably allow the user topre-treat the specimen.

In this case, it may be preferable that the pre-treatment of thespecimen include a process of agitating the specimen, and controller(30) perform control of causing display unit (131) to display how toagitate the specimen. Such a configuration makes it possible to agitatethe specimen in accordance with the instruction of display unit (131)even when the user has insufficient knowledge about how to agitate thespecimen.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that the analyzer include output unit (130)which outputs an analysis result, and controller (30) cause output unit(130) to output the analysis result on the specimen and reference valueinformation corresponding to the subject attribute information. Such aconfiguration makes it possible for the user to easily check thevalidity of the analysis result by comparing the analysis result on thespecimen and the reference value information.

In this case, it may be preferable that the reference value informationinclude normal value range information corresponding to an attribute ofthe subject. Such a configuration makes it possible for the user to moreeasily check the validity of the analysis result by comparing theanalysis result on the specimen and the reference value information.

In above-described specimen analyzer (100) which includes output unit(130), it may be preferable that output unit (130) include display unit(131) and print unit (135), and controller (30) perform control ofcausing print unit (135) to output the analysis result by printing. Sucha configuration makes it possible for the user to easily check theanalysis result because the analysis result is outputted in the form ofprint even when the amount of the analysis result is large.

In above-described specimen analyzer (100) which includes output unit(130), it may be preferable that output unit (130) include display unit(131) and print unit (135), and controller (30) perform control ofcausing display unit (131) to display a warning message when theanalysis result includes an abnormal value. Such a configuration makesit possible to effectively call the user's attention because the warningmessage is displayed by display unit (131). This makes it easier for theuser to check the validity of the analysis result.

In this case, it may be preferable that controller (30) perform controlof causing display unit (131) to display a message instructing a retestwhen the analysis result includes the abnormal value. Such aconfiguration makes it possible to prompt the user to perform retestusing the message when abnormal analysis results are obtained in thecondition in which the user without expertise uses the analyzer. Thismakes it possible to seek an instruction of the ordering doctor or thelike even if the user without expertise does not understand the analysisresults.

In above-described specimen analyzer (100) configured such that displayunit (131) displays the warning message, it may be preferable that in acondition in which an abnormal value included in the analysis result iswithin a preset numerical range, controller (30) causes print unit (135)to print the analysis result and the abnormal value in the analysisresult to be omitted from printing. Such a configuration makes itpossible to, for example, strongly prompt the user to perform retestbecause the abnormal value is not provided to the ordering doctor or thelike. In the case of simple specimen analyzer (100) with small displayunit (131) in particular, by printing the predetermined message insteadof printing the abnormal value, the configuration is useful in making anappropriate diagnosis in clinical examination because the orderingdoctor or the like is allowed to consider performing retest by use of amore accurate test apparatus or at a specialized examination facility.

In this case, it may be preferable that controller (30) perform controlof substituting the abnormal value for a substitute indication andcausing print unit (135) to print the substitute indication in acondition in which the abnormal value is omitted from printing. Such aconfiguration makes it possible to exclude the abnormal value from thecontent to be printed while the substitute indication allows the user torecognize analysis results are obtained. Hence, the user does notmisunderstand that the analysis has not been performed for a reason,unlike the case of simply removing an abnormal value.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that analysis unit (10) perform the samemeasurement regardless of the subject attribute information. Thisconfiguration makes it possible to prevent analysis unit (10) fromperforming complicated processing compared to the case of performingdifferent measurements depending on the subject attribute information.

In above-described specimen analyzer (100) according to the firstaspect, it may be preferable that the specimen be blood, and analysisunit (10) analyze the number of blood cells and a concentration of acomponent contained in blood. To be more specific, specimen analyzer(100) is a blood cell counting apparatus. The blood cell countingapparatus counts the number of blood cells contained in a predeterminedvolume of a blood specimen. The analysis results of the blood cellcounting apparatus can include analysis values such as the number ofcell components such as various blood cells and platelets, a measurementvalue of e.g. a concentration of a component in blood, ratios of bloodcells based on the measured values, an average volume, and adistribution width. The blood cell counting apparatus performs some ofthe blood tests widely used in clinical examination. The analysisresults of the blood cell counting apparatus are important in the fieldof clinical examination because they are related to various types ofdiseases. For this reason, the invention is suitably applied to bloodcell counting apparatuses, the invention being capable of measuring thespecimen after the subject attribute information is more reliablyinputted in order that the user without expertise can evaluate theanalysis results.

A specimen analysis method according to a second aspect of the inventionincludes: inputting subject attribute information; measuring a specimencollected from a subject; causing analysis unit (10) to analyze thespecimen based on a measurement result of the specimen and the inputtedsubject attribute information; and prohibiting analysis unit (10) fromanalyzing the specimen until the subject attribute information isinputted.

As described above, the specimen analysis method according to the secondaspect prohibits analysis unit (10) from analyzing the specimen untilthe subject attribute information is inputted. Analysis operations forthe specimen are not performed until the subject attribute informationis inputted. Thus, it is possible to perform analysis operations for thespecimen after the subject attribute information is actually inputted.As a result, it is possible to output analysis results based on thesubject attribute information, providing a specimen analysis methodwhich enables the user to evaluate with certainty the analysis resultseven without expertise.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a diagram for explaining an overview of a specimen analyzer;

FIG. 2 is a perspective view illustrating a configuration example of thespecimen analyzer;

FIG. 3 is a schematic view illustrating an internal configurationexample of the specimen analyzer;

FIG. 4 is a block diagram illustrating a configuration of the specimenanalyzer;

FIG. 5 is a flowchart illustrating an example of operations of thespecimen analyzer;

FIG. 6 is a flowchart illustrating an example of a sample measurementprocess;

FIG. 7 is a diagram illustrating display example 1 for connecting anEthernet cable;

FIG. 8 is a diagram illustrating display example 2 for connecting anEthernet cable;

FIG. 9 is a diagram illustrating display example 1 for printerconfirmation;

FIG. 10 is a diagram illustrating display example 2 for printerconfirmation;

FIG. 11 is a diagram illustrating display example 3 for printerconfirmation;

FIG. 12 is a diagram illustrating display example 4 for printerconfirmation;

FIG. 13 is a diagram illustrating a display example for barcode readerconfirmation;

FIG. 14 is a diagram illustrating a display example for connectingvarious types of tubes;

FIG. 15 is a diagram illustrating display example 1 for setting areagent;

FIG. 16 is a diagram illustrating display example 2 for setting areagent;

FIG. 17 is a diagram illustrating display example 3 for setting areagent;

FIG. 18 is a diagram illustrating display example 4 for setting areagent;

FIG. 19 is a diagram illustrating display example 5 for setting areagent;

FIG. 20 is a diagram illustrating display example 6 for setting areagent;

FIG. 21 is a diagram illustrating display example 7 for setting areagent;

FIG. 22 is a diagram illustrating display example 1 for cleaning byCELLCLEAN;

FIG. 23 is a diagram illustrating display example 2 for cleaning byCELLCLEAN;

FIG. 24 is a diagram illustrating display example 3 for cleaning byCELLCLEAN;

FIG. 25 is a diagram illustrating display example 4 for cleaning byCELLCLEAN;

FIG. 26 is a diagram illustrating display example 1 for QC measurement;

FIG. 27 is a diagram illustrating display example 2 for QC measurement;

FIG. 28 is a diagram illustrating display example 3 for QC measurement;

FIG. 29 is a diagram illustrating display example 4 for QC measurement;

FIG. 30 is a diagram illustrating display example 5 for QC measurement;

FIG. 31 is a diagram illustrating display example 6 for QC measurement;

FIG. 32 is a diagram illustrating display example 7 for QC measurement;

FIG. 33 is a diagram illustrating display example 1 for samplemeasurement;

FIG. 34 is a diagram illustrating display example 2 for samplemeasurement;

FIG. 35 is a diagram illustrating display example 3 for samplemeasurement;

FIG. 36 is a diagram illustrating display example 4 for samplemeasurement;

FIG. 37 is a diagram illustrating display example 5 for samplemeasurement;

FIG. 38 is a diagram illustrating display example 6 for samplemeasurement;

FIG. 39 is a diagram illustrating display example 7 for samplemeasurement;

FIG. 40 is a diagram illustrating display example 8 for samplemeasurement;

FIG. 41 is a diagram illustrating display example 1 for maintenance;

FIG. 42 is a diagram illustrating display example 2 for maintenance;

FIG. 43 is a diagram illustrating display example 3 for maintenance;

FIG. 44 is a diagram illustrating display example 4 for maintenance;

FIG. 45 is a diagram illustrating display example 5 for maintenance;

FIG. 46 is a diagram illustrating display example 6 for maintenance;

FIG. 47 is a diagram illustrating display example 7 for maintenance;

FIG. 48 is a diagram illustrating display example 8 for maintenance;

FIG. 49 is a diagram illustrating an example of print content of printedsheet;

FIG. 50 is a diagram for explaining a result displaying section of theprinted sheet;

FIG. 51 is a diagram for explaining rules of outputting analysis resultson the printed sheet;

FIG. 52 is a diagram for explaining first determination ranges;

FIG. 53 is a diagram for explaining numerical ranges for evaluatinganalysis results for an infant;

FIG. 54 is a diagram for explaining numerical ranges for evaluatinganalysis results for a youth;

FIG. 55 is a diagram for explaining numerical ranges for evaluatinganalysis results for an adult;

FIG. 56 is a diagram for explaining a first modification of a printingembodiment of the analysis results;

FIG. 57 is a diagram for explaining a second modification of theprinting embodiment of the analysis results;

FIG. 58 is a diagram for explaining first and second modifications ofthe rules of outputting the analysis results; and

FIG. 59 is a diagram illustrating an example of an error display screen.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Hereinafter, an embodiment is described based on the drawings.

[Overview of Specimen Analyzer]

With reference to FIG. 1, an overview of specimen analyzer 100 accordingto an embodiment is described.

Specimen analyzer 100 according to the embodiment is an analysisapparatus for analyzing a specimen collected from a subject. Asillustrated in FIG. 1, specimen analyzer 100 includes analysis unit 10,input unit 20, and controller 30.

The subject is a human in most cases, but may be an animal other than ahuman. Specimen analyzer 100 performs measurement or analysis forclinical examination of the specimen collected from, for example, apatient. The specimen is blood of the subject, for example. Note thatthe specimen may be, for example, a body fluid other than urine andblood of the subject. Also, the specimen may be, for example, part ofthe tissue or a cell of the subject. In addition, the specimen may be,for example, DNA or RNA. Specimen analyzer 100 is, for example, ananalysis apparatus which analyzes blood. For example, specimen analyzer100 is a blood cell counting apparatus. Here, specimen analyzer 100 maybe an analysis apparatus which analyzes a body fluid other than urineand blood of the subject. Moreover, specimen analyzer 100 may be ananalysis apparatus which analyzes, for example, part of the tissue or acell of the subject, DNA, or RNA.

Analysis unit 10 analyzes the specimen collected from the subject.Analysis unit 10 includes, for example, a CPU and a memory. Analysisunit 10 analyzes the specimen based on results obtained by measuring thespecimen and on attribute information of the subject.

Analysis unit 10 measures the specimen collected from the subject. Forexample, analysis unit 10 includes one or more detectors correspondingto the analysis items, and measures or detects a target component in thespecimen. The number of analysis items may be one or more. In addition,analysis unit 10 performs the same measurement regardless of the subjectattribute information. Thus, it is possible to prevent analysis unit 10from performing complicated processing compared to the case ofperforming different measurements depending on the subject attributeinformation.

Input unit 20 receives an input of subject attribute information. Inputunit 20 includes, for example, a touch panel, a keyboard, a mouse, andan identifier reader. The subject attribute information includesinformation on the subject necessary to analyze the specimen. Thesubject attribute information includes, for example, information on theage. For example, the information on the age includes at least one ofthe age, an age group, a birth year, and a birth date. For example, theage group is a range of teens, twenties, thirties etc., or ages aroundtwenty, thirty, forty, etc. Here, when the specimen collected from thesubject is to be analyzed, the criteria for the results of measuring thespecimen differ depending on the attributes of the subject. For example,the normal range and the erroneous range for the results of measuringthe specimen differ depending on the attributes of the subject such asage or sex. To be more specific, when analyzing the specimen, theattributes of the subject are required. Note that the subject attributeinformation may include the age range of the subject. In addition, thesubject attribute information may include a value relating to the bodyof the subject. For example, the subject attribute information mayinclude the height and the weight of the subject. Moreover, the subjectattribute information may include information on whether or not thesubject is pregnant. Note that subject information unnecessary toanalyze the specimen does not have to be included as the subjectattribute information. For example, the name, the nationality, theidentification number, and the phone number of the subject do not haveto be included in the subject attribute information.

Controller 30 is configured to control the units of specimen analyzer100. Controller 30 includes, for example, a CPU and a memory. Controller30 is configured to perform control of causing analysis unit 10, foreach specimen, to be incapable of analyzing the specimen unless thesubject attribute information is inputted with input unit 20. To be morespecific, at step S1 of input process for the subject attributeinformation in FIG. 1, determination is made as to whether or not inputunit 20 inputted the subject attribute information. If the subjectattribute information is inputted, the processing proceeds to step S2.On the other hand, if the subject attribute information is not inputted,the determination of step S1 is repeated until the subject attributeinformation is inputted. At step S2, analysis unit 10 is allowed toanalyze the specimen. Thus, the subject attribute information inputprocess finishes. To be more specific, controller 30 prohibits, for eachspecimen, the analysis unit from analyzing the specimen until thesubject attribute information is inputted.

As described above, analysis unit 10 is, for each specimen, incapable ofanalyzing the specimen unless the subject attribute information isinputted with input unit 20. Analysis operations for the specimen arenot performed until the subject attribute information is inputted. Thus,it is possible to perform analysis operations for the specimen after thesubject attribute information is actually inputted. As a result, it ispossible to output analysis results based on the subject attributeinformation, enabling the user to evaluate with certainty the analysisresults even without expertise. Note that in this embodiment, analysisoperations for the specimen are not performed, for each specimen, untilthe subject attribute information is inputted, but the invention is notlimited to this configuration. In the case of measuring in sequence twoor more specimens collected from one subject, one may use the subjectattribute information inputted for the first specimen to analyze theother specimens.

Moreover, controller 30 performs, for each specimen, control of causinganalysis unit 10 to be incapable of measuring the specimen unless thesubject attribute information is inputted with input unit 20. Thus,since the specimen is not measured until the subject attributeinformation is inputted, analysis based on the measurement results isnot performed. As a result, it is possible to analyze the specimen afterthe subject attribute information is more reliably inputted.

Furthermore, controller 30 waits, for each specimen, to proceed to thenext process concerning the analysis of the specimen until subjectattribute information is inputted input unit 20. Thus, it is possible tomeasure the specimen after the subject attribute information is morereliably inputted because specimen analyzer 100 cannot advance, for eachspecimen, the processing unless the subject attribute information isinputted with input unit 20.

[Configuration Example of Specimen Analyzer]

With reference to FIG. 2 to FIG. 57, a configuration example of specimenanalyzer 100 is described.

(Overall Configuration)

In the example illustrated in FIG. 2, specimen 101 is blood in specimenanalyzer 100, and specimen analyzer 100 is a blood cell countingapparatus. The blood cell counting apparatus is an apparatus whichcounts the number of blood cells contained in a predetermined volume ofblood specimen. Analysis unit 120 analyzes the number of blood cells andconcentrations of the components contained in the blood. [0042] Whenspecimen container 103 containing specimen 101 is set, specimen analyzer100 aspirates specimen 101 in specimen container 103 and analyzes thespecimen. For example, a container in the shape of a generally-usedblood collection tube can be used as specimen container 103. Specimencontainer 103 is, for example, a vacuum blood collection tube cappedwith a rubber cap or an open blood collection tube which has an opening.Specimen 101 to be contained in specimen container 103 is, for example,whole blood of a subject (human), and is added with an anticoagulant.The necessary amount of added anticoagulant is, for example, 10 μL to 15μL inclusive.

Specimen analyzer 100 has apparatus body 110 which includes analysisunit 120 for analyzing the specimen collected from the subject, outputunit 130 for outputting analysis results 102 of analysis unit 120, andcontroller 140. Moreover, specimen analyzer 100 includes informationread unit 150 connected to apparatus body 110. Further, specimenanalyzer 100 is connected to various types of consumables 104 used alongwith analysis operation for specimen 101.

Apparatus body 110 is a unit provided with analysis unit 120, outputunit 130, etc. in a box-shaped housing. Apparatus body 110 is configuredas a small blood cell counting apparatus which can be a desktop one,including information read unit 150 and consumables 104. Analysis unit120 and controller 140 are built in apparatus body 110.

Container set unit 111 is provided at a front and lower portion ofapparatus body 110. Container set unit 111 is configured such that it isopenable and closable from the front surface of apparatus body 110 inthe direction toward the user (see FIG. 3). Using container set unit111, specimen container 103 containing specimen 101 is set in apparatusbody 110.

In the example illustrated in FIG. 2, analysis unit 120 is configured toanalyze multiple analysis items. As an example, as measurement items byanalysis unit 120, the analysis items include e.g. eight items: whiteblood cell count (WBC), red blood cell count (RBC), hemoglobinconcentration (HGB), hematocrit value (HCT), mean corpuscular volume(MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobinconcentration (MCHC), and platelet count (PLT). As analysis items to beanalyzed on the basis of the analysis results of the measurement items,the analysis items include e.g. nine items: WBC-small cell ratio (%Lymph), WBC-middle cell ratio (% OtherWBC), WBC-large cell ratio (%Neut), WBC-small cell count (#Lymph), WBC-middle cell count (#OtherWBC),WBC-large cell ratio (#Neut), red blood cell distribution width (RDW-SDand RDW-CV), mean platelet volume (MPV). In this example, the number ofanalysis items of analysis unit 120 is 17.

Output unit 130 outputs various types of information on specimenanalyzer 100 to the user. In the example of FIG. 2, output unit 130includes display unit 131 and print unit 135. In the example of FIG. 2,display unit 131 is an LCD (liquid crystal display), and is disposed ata front and upper portion of apparatus body 110. In the example of FIG.2, print unit 135 is a thermal printer which prints on thermal paperwith use of heat, and is located on an upper surface of apparatus body110.

Moreover, specimen analyzer 100 includes manual input unit 132 whichreceives an input operation of the user. In the example of FIG. 2,manual input unit 132 is a touch panel provided on display unit 131. Theuser is allowed to input information and perform various operations bytouching the icons displayed on display unit 131. Also, display unit 131displays an instruction on how to perform a series of operationsconcerning the analysis of the specimen. In addition, display unit 131includes a touch panel configured to display input unit 20 (See FIG. 1).This makes it possible to simplify the analyzer configuration and todownsize the analyzer compared to the case of providing input unit 20and display unit 131 separately.

In the example of FIG. 2, information read unit 150 is configured toread an identifier provided on each of consumables 104, and to receiveinputted information. To be more specific, information read unit 150 isa read apparatus such as a barcode reader, a two-dimensional codereader, and a camera. The identifier is a barcode or a two-dimensionalcode.

In the example of FIG. 2, inputting of information on consumables 104 bymanual input unit 132 is not permitted, but inputting by informationread unit 150 is permitted. Controller 140 determines whether to useconsumables 104 based on information on consumables 104 inputted byinformation read unit 150. To be more specific, controller 140 allowsuse of consumables 104 if information on consumables 104 inputted byinformation read unit 150 is registered on server 200.

Consumables 104 are consumed along with analysis operation of specimen101 by specimen analyzer 100. Consumables 104 contain the reagent usedfor the analysis of specimen 101. In the example of FIG. 2, used asconsumables 104 are diluted solution container 104 a containing adiluted solution for diluting specimen 101 and hemolyzer container 104 bcontaining a hemolyzer which hemolyzes blood cells. Moreover,consumables 104 contain a cleaning agent for cleaning specimen analyzer100. In the example of FIG. 2, used as consumable 104 is cleaning agentcontainer 104 c containing a cleaning agent for cleaning a fluid circuitin the apparatus. Note that the diluted solution is used for a cleaningprocess. The cleaning agent contains a cleaning component such as asodium hypochlorite solution, and has more cleaning power than thediluted solution. Cleaning with use of the cleaning agent is regularlycarried out each time a predetermined period elapses, e.g. one week.Cleaning with use of the diluted solution is carried out more frequentlythan the cleaning with use of the cleaning agent each time the analysisof specimen 101 is performed, for example. The identifiers provided onconsumables 104 have information on consumables 104 recorded therein.Information on consumables 104 includes at least one of the type ofconsumable 104, expiration date, lot number, and serial number.

As an example, in the example of FIG. 2, “pocH-pack D (manufactured bySysmex Corporation, registered trademark)” is preferably used as thediluted solution, “pocH-pack L (manufactured by Sysmex Corporation,registered trademark)” is preferably used as the hemolyzer, and“CELLCLEAN (manufactured by Sysmex Corporation, registered trademark)”is preferably used as the cleaning agent.

(Configuration of Each of Units of Specimen Analyzer)

In the example illustrated in FIG. 3, print unit 135 is configured suchthat it can change the size of print sheet 136, and is configured toprint analysis results 102 on the same surface of a single piece ofprint sheet 136. To be more specific, print unit 135 includes sheet setunit 135 a which holds print sheet 136 which is elongated, and changesthe size of print sheet 136 by printing on an area of print sheet 136with an appropriate length depending on the print amount. In the exampleof FIG. 3, set to sheet set unit 135 a is print sheet 136 which is rollpaper being rolled thermal paper which is elongated with a predeterminedwidth. In addition, print unit 135 includes print head 135 b which heatsprint sheet 136, and prints using print head 135 b while forwardingrolled print sheet 136 with a not-illustrated motor. Thus, print unit135 prints on an area of print sheet 136 with an appropriate lengthdepending on the amount of information to be printed including analysisresults 102. The user cuts the printed sheet sent from print unit 135 inan appropriate length, and acquires one sheet of printed sheet on whichanalysis results 102 are printed.

Container set unit 111 includes adapter 112 for holding a lower portionof specimen container 103. When open, container set unit 111 is capableof holding specimen container 103 in an upright state. Here, in additionto specimen container 103, it is possible to set, to container set unit111, a QC reagent container (not illustrated) which contains a controlspecimen (hereinafter referred to as QC reagent) for quality control andcleaning agent container 104 c.

Analysis unit 120 includes pipette 121 for aspirating specimen 101 fromspecimen container 103 set to container set unit 111 and drive mechanism122 for pipette 121. Moreover, analysis unit 120 includes detector 123for detecting components in specimen 101 and fluid circuit 124 forfeeding liquid. Furthermore, analysis unit 120 (see FIG. 4) includes acomputer which has processor 141 and memory 142.

Pipette 121 is an aspiration tube for measuring the amount of a liquid.Drive mechanism 122 includes linear mechanisms made up of e.g. aguiderail, a motor, and a belt pulley mechanism, and holds pipette 121.Pipette 121 is provided at a position above specimen container 103 setin container set unit 111, and is configured such that it can move inthe up-down direction and in the horizontal direction. Pipette 121 isconnected to a syringe pump provided in fluid circuit 124, and iscapable of aspirating a predetermined amount of specimen 101 containedin specimen container 103. Pipette 121 is moved down from a positionabove specimen container 103, enters the inside of specimen container103, and is allowed to aspirate a predetermined amount of specimen 101by fluid circuit 124. Moreover, pipette 121 is moved by drive mechanism122 to a position above a mixing chamber of fluid circuit 124 to bedescribed later and to a position above container unit 123 a of detector123, and is allowed to aspirate and discharge liquid by fluid circuit124 at each of the positions. In the case where the QC reagent containercontaining the QC reagent and the cleaning agent container are set incontainer set unit 111, pipette 121 can also aspirate the QC reagent andthe cleaning agent by performing the same or similar operations.

Fluid circuit 124 includes e.g. a mixing chamber, a pressure source, asyringe pump, a diluted solution, chambers for hemolyzer and wasteliquid, a cleaning Spitz for cleaning pipette 121, various valves forswitching liquid feed, and a sensor. Fluid circuit 124 connects pipette121 and detector 123 together in a fluid manner via a flow path such asa liquid feed tube. Moreover, fluid circuit 124 is connected in a fluidmanner to external connectors 124 a provided on the back surface ofapparatus body 110. The number of external connectors 124 a provided isthree, which are separately connected via connection tubes 105 todiluted solution container 104 a, hemolyzer container 104 b, and wasteliquid container 106.

Fluid circuit 124 mixes a predetermined amount of specimen 101 aspiratedby pipette 121 and a predetermined amount of diluted solution in amixing chamber to prepare an RBC/PLT measurement specimen, which is adiluted specimen with a predetermined ratio. In addition, fluid circuit124 mixes a predetermined amount of specimen 101, a predetermined amountof diluted solution, and a predetermined amount of hemolyzer to preparea WBC/HGB measurement specimen which includes a mixed solution of bloodspecimen, diluted solution, and hemolyzer.

Detector 123 is configured to measure the target components in specimen101 corresponding to the analysis items. In the example of FIG. 3,detector 123 measures multiple items. In the example of FIG. 3, detector123 is configured to perform measurement in accordance with multiplemeasurement principles depending on the target components of theanalysis items.

To be more specific, detector 123 performs RBC measurement and PLTmeasurement using a sheath flow electrical resistance method. Detector123 performs WBC measurement using an electrical resistance method.Detector 123 includes resistance detector 123 b for performingmeasurement using the sheath flow electrical resistance method and theelectrical resistance method. Moreover, detector 123 performs HGBmeasurement using a colorimetric method. Detector 123 includes opticaldetector 123 c for performing measurement using the colorimetric method.

The sheath flow electrical resistance method forms a sheath flow of aspecimen flow and a flow of sheath liquid surrounding the specimen flow,and causes the sheath flow to pass through an orifice. Electrodes areprovided in front and rear of the orifice, respectively, in the flowdirection. A pulse signal, which represents the presence and volumeinformation of each blood cell, is measured based on the change inresistance between the electrodes generated by the blood cells passingthrough the orifice.

Here, the diluted solution forms the flow of sheath liquid, and theRBC/PLT measurement specimen forms the specimen flow. Resistancedetector 123 b includes an orifice and a pair of electrodes used formeasurement. Analysis unit 120 obtains the red blood cell count (RBC),the platelet count (PLT), and the hematocrit value (HCT) from themeasured count value of the pulse signal.

The electrical resistance method causes the WBC/HGB measurement specimento pass through an orifice, and measures a pulse signal which representsthe presence and volume information of each blood cell based on thechange in resistance between the front and rear electrodes of theorifice. Analysis unit 120 obtains the white blood cell count (WBC) fromthe measured count value of the pulse signal.

The colorimetric method causes a light source to emit measurement lightto the WBC/HGB measurement specimen, and detects the measurement lighthaving passed through the specimen with a light receiving element.Additionally, the same process is also performed on the dilutedsolution, and analysis unit 120 obtains the hemoglobin concentration(HGB) based on the difference in absorbance between the diluted solutionand the WBC/HGB measurement specimen. Optical detector 123 c includesthe light source and the light receiving element used for measurement.The light source is, for example, an LED, and the light receivingelement is, for example, a photodiode.

The mean corpuscular volume (MCV), the mean corpuscular hemoglobin(MCH), and the mean corpuscular hemoglobin concentration (MCHC) arecalculated by analysis unit 120 from the measurement values of the redblood cell count (RBC), the platelet count (PLT), and the hematocritvalue (HCT), respectively.

Based on the analysis results of the measurement items, analysis unit120 obtains the analysis items of the WBC-small cell ratio (% Lymph),the WBC-middle cell ratio (% OtherWBC), the WBC-large cell ratio (%Neut), the WBC-small cell count (#Lymph), the WBC-middle cell count(#OtherWBC), the WBC-large cell ratio (#Neut), the red blood celldistribution width (RDW-SD and RDW-CV), the mean platelet volume (MPV).

As illustrated in FIG. 4, controller 140 includes processor 141 such asa CPU and memory 142. Memory 142 can include a volatile memory such as aRAM, and a non-volatile memory such as a ROM, a flash memory, and a harddisk. Memory 142 has, for example, a control program for controllingspecimen analyzer 100, analysis program for obtaining analysis results102, and display screen data of display unit 131 recorded therein.Processor 141 executes a program recorded in memory 142 and therebyfunctions as controller 140 which performs operation control of unitssuch as drive mechanism 122, fluid circuit 124, detector 123, displayunit 131, and print unit 135. Moreover, processor 141 functions as partof analysis unit 120 which obtains analysis results 102 of the analysisitems by executing the programs recorded in memory 142. Controller 140and analysis unit 120 may be configured as a separate processor andmemory. Furthermore, controller 140 obtains information inputted throughmanual input unit 132 and processes that information. What is more,controller 140 controls read operation by information read unit 150through an external IF, and processes the read information. Stillfurther, controller 140 is capable of connecting to network 250 viacommunication unit 145, and thus accessing management server 200 ofspecimen analyzer 100. Communication unit 145 includes a communicationinterface, and establishes cabled or wireless connection to network 250.Communication unit 145 connects to network 250 via, for example, anEthernet cable.

Controller 140 is configured to advance, with the series of operationsperformed in accordance with the instruction of display unit 131, aprocess concerning the analysis of the specimen, and controller 140 isconfigured to wait to proceed to a next process until the subjectattribute information is inputted. This makes it possible for the usereven with insufficient knowledge about the operation procedures toperform operations in accordance with the instruction of display unit131, which facilitates the operations of specimen analyzer 100. Inaddition, controller 140 is configured to perform control of causingdisplay unit 131 to display an instruction to input the subjectattribute information. This allows the user to reliably input thesubject attribute information with the help of the display of displayunit 131.

In addition, controller 140 is configured to cause display unit 131 todisplay a screen to confirm whether or not the subject attributeinformation is correct when the subject attribute information isinputted. This allows the user to reliably input the correct subjectattribute information.

Furthermore, controller 140 is configured to perform control of causingdisplay unit 131 to display an instruction for pre-treatment of thespecimen and time necessary for the pre-treatment of the specimen. Also,controller 140 is configured to wait to proceed to a next processconcerning the analysis of the specimen until the time for pre-treatmentelapses. This makes it possible to reliably allow the user to pre-treatthe specimen. More specifically, the pre-treatment of the specimenincludes a process of agitating the specimen. Controller 140 isconfigured to perform control of causing display unit 131 to display howto agitate the specimen. This makes it possible to agitate the specimenin accordance with the instruction of display unit 131 even when theuser has insufficient knowledge about how to agitate the specimen.

In addition, controller 140 is configured to cause output unit 130 tooutput the analysis result on the specimen together with reference valueinformation corresponding to the subject attribute information. Thismakes it possible for the user to easily check the validity of theanalysis result by comparing the analysis result on the specimen and thereference value information. The reference value information includesnormal value range information corresponding to an attribute of thesubject. This makes it possible for the user to more easily check thevalidity of the analysis result by comparing the analysis result on thespecimen and the reference value information.

Also, controller 140 is configured to perform control of causing printunit 135 to output the analysis result by printing. This makes itpossible for the user to easily check the analysis result because theanalysis result is outputted in the form of print even when the amountof the analysis result is large. In other words, controller 140 causesprint unit to print the analysis result but causes display unit not tooutput the analysis result.

Additionally, controller 140 is configured to perform control of causingdisplay unit 131 to display a warning message in a case where theanalysis result includes an abnormal value. This makes it possible toeffectively call the user's attention because the warning message isdisplayed by display unit 131. This makes it easier for the user tocheck the validity of the analysis result. Also, controller 140 isconfigured to perform control of causing display unit 131 to display amessage instructing a retest in a case where the analysis resultincludes the abnormal value. This makes it possible to prompt the userto perform retest using the message when abnormal analysis results areobtained in the case where the user without expertise uses the analyzer.This makes it possible to seek an instruction of the ordering doctor orthe like even if the user without expertise does not understand theanalysis results.

Furthermore, in a case where a certain abnormal value included in theanalysis result is within a preset numerical range, controller 140 isconfigured to perform control of causing print unit 135 to print theanalysis result and the certain abnormal value in the analysis result tobe omitted from printing. This makes it possible to, for example,strongly prompt the user to perform retest because the certain abnormalvalue is not provided to the ordering doctor or the like. In the case ofsimple specimen analyzer 100 with small display unit 131 in particular,by printing the predetermined message instead of printing the certainabnormal value, it is useful in making an appropriate diagnosis inclinical examination because the ordering doctor or the like is allowedto consider performing retest by use of a more accurate test apparatusor at a specialized examination facility.

For example, controller 140 is configured to perform control ofsubstituting the certain abnormal value for a substitute indication andcausing print unit 135 to print the substitute indication in a conditionin which the certain abnormal value is omitted from printing. Such aconfiguration makes it possible to exclude the certain abnormal valuefrom the content to be printed while the substitute indication allowsthe user to recognize certain analysis results are obtained. Hence, theuser does not misunderstand that the analysis has not been performed fora reason, unlike the case of simply removing a certain abnormal value.

(Description on Server)

Registered with storage unit 210 of server 200 are serial numbers ofindividual specimen analyzers 100. To be more specific, the user isallowed to use only specimen analyzers 100 registered with server 200.Registered with storage unit 220 of server 200 are lot numbers andserial numbers of reagents. To be more specific, the user is allowed touse only the reagents registered with server 200 in specimen analyzer100. Moreover, stored in storage unit 220 of server 200 is informationon a QC reagent. Information on a QC reagent is stored associated withthe lot number of that QC reagent. To be more specific, information on aQC reagent includes information on a measurement range of the QCreagent. For example, QC reagents used include a High QC reagentcontaining a highly concentrated component, a Normal QC reagentcontaining a normally concentrated component, and a Low QC reagentcontaining a low concentrated component. A normal value of themeasurement result is set for each QC reagent depending on High, Normal,and Low. Moreover, the QC reagent has a varying normal value dependingon the lot. In light of this, storage unit 220 of server 200 storesranges of normal values in the case of measuring QC reagents dependingon the types High, Normal, and Low, and the lot number.

[Operation Example of Specimen Analyzer]

With reference to FIG. 5, an operation example of specimen analyzer 100is described.

When the power is turned ON at step S10, a startup process is performedat step S11. To be more specific, the system is automatically checked.Also, the inside of the apparatus is automatically cleaned.Additionally, blank check is performed.

At step S12, quality control is executed. The quality control isperformed at predetermined intervals. Display unit 131 displays a screenrequiring quality control at predetermined intervals. The user inputsdata concerning quality control in accordance with what is beingdisplayed, and instructs to measure quality control substances.

At step S13, a patient sample as a specimen is measured. Display unit131 displays a screen of an instruction for sample measurement. The userperforms sample measurement instruction in accordance with what is beingdisplayed. At step S14, the measurement results are printed. To be morespecific, the measured and analyzed results are printed and outputtedfrom print unit 135. Note that display unit 131 does not display themeasurement results.

[Description on Sample Measurement Process]

With reference to FIG. 6, an example of a sample measurement process byspecimen analyzer 100 is described. In the example illustrated in FIG.6, specimen analyzer 100 measures and analyzes the sample of a patientas a specimen.

At step S20, a sample container is checked. To be more specific, displayunit 131 displays images of the types of sample containers available.The user checks the sample container by comparing the images and theactual sample container. At step S21, an operator ID is inputted. To bemore specific, the user inputs an ID for identifying the operator inaccordance with the instructions of display unit 131.

At step S22, a patient ID is inputted. To be more specific, the userinputs an ID for identifying the patient in accordance with theinstructions of display unit 131. At step S23, the date of birth of thepatient is inputted. To be more specific, the user inputs the date ofbirth of the patient being the sample to be measured in accordance withthe instructions of display unit 131.

At step S24, a measurement pre-treatment is performed. To be morespecific, display unit 131 displays the instructions on thepre-treatment. The user performs the pre-treatment such as heating andagitating of the sample in accordance with the instructions of displayunit 131. At step S25, a sample container is set. To be more specific,display unit 131 displays the instructions on the setting of the samplecontainer. The user sets the sample container in specimen analyzer 100in accordance with the instructions of display unit 131.

At step S26, the sample is measured. When the measurement of the samplefinishes, measurement results are printed at step S27. To be morespecific, after the measurement finishes, display unit 131 displays abutton for starting of the printing. When the user operates the buttonfor starting of the printing, print unit 135 prints the measurementresult. The printing results are, for example, the name of the hospital,its location, the name of the measurement apparatus, the date and timeof measurement, the operator ID, patient ID, the date of birth of thepatient, the measurement results, messages, information on the referencevalue, and a print end mark.

At step S28, the sample container is removed. To be more specific,display unit 131 displays the instructions for removing the samplecontainer. The user removes the sample container from specimen analyzer100 in accordance with the instructions of display unit 131. At stepS29, determination is made as to whether or not there is a samplecontainer. If there is a sample container, the process returns to stepS28, and if there is no sample container, the sample measurement processfinishes.

[Display Example of Display Unit]

With reference to FIG. 7 to FIG. 48, a display example of display unit131 in a case of using specimen analyzer 100 is described. It ispossible to operate specimen analyzer 100 by following a series ofinstructions displayed on display unit 131.

(Display Example when Connecting Ethernet Cable)

With reference to FIG. 7 and FIG. 8, a display example when connectingan Ethernet cable is described.

It is impossible to use specimen analyzer 100 unless it is connected toserver 200 via network 250. To be more specific, it is possible to usespecimen analyzer 100 if it is registered with server 200. It isnecessary to connect to server 200 in order to check whether or notspecimen analyzer 100 is registered. Specimen analyzer 100 is connectedto network 250 with an Ethernet cable. To this end, it is necessary toconnect an Ethernet cable to specimen analyzer 100.

To begin with, when specimen analyzer 100 is set and the power is turnedon, display unit 131 first displays a screen for connecting an Ethernetcable. To be more specific, as illustrated in FIG. 7, display unit 131displays screen P1. Screen P1 shows a picture and an instruction on howto insert the Ethernet cable to specimen analyzer 100. Also, screen P1shows Complete button P1 a. When Complete button P1 a is pressed,display unit 131 displays screen P2. Screen P2 shows Continue button P2a. When Continue button P2 a is pressed, display unit 131 displaysscreen P3, as illustrated in FIG. 8. Thus, communication unit 145 ofspecimen analyzer 100 starts connection to server 200.

If the connection fails while screen P3 is being displayed, display unit131 displays screen P4. Screen P4 shows Call TAC button P4 a andContinue button P4 b. When Call TAC button P4 a is pressed, display unit131 displays screen P5. When Continue button P4 b is pressed, displayunit 131 again displays screen P3.

Screen P5 shows error details. If the user telephones to a TAC(Technical Assistance Center) and communicates the description of screenP5, he/she can receive support smoothly. Screen P5 shows Return buttonP5 a. When Return button P5 a is pressed, display unit 131 displaysscreen P4.

If the connections succeeds while screen P3 is being displayed, displayunit 131 displays screen P6. Screen P6 shows Continue button P6 a. WhenContinue button P6 a is pressed, the instructions to connect an Ethernetcable stop being displayed. Then, the screen proceeds to a screen ofprinter confirmation.

(Display Example at Printer Confirmation)

With reference to FIG. 9 to FIG. 12, a display example at printerconfirmation is described.

Display unit 131 displays a screen for confirming a printer as printunit 135. As illustrated in FIG. 9, display unit 131 displays screenP11. Screen P11 shows a picture and an instruction on how to open a doorof the printer. Also, screen P11 shows Complete button P11 a. WhenComplete button P11 a is pressed, display unit 131 displays screen P12.Screen P12 shows a picture and an instruction on how to remove paperfrom the printer. Also, screen P12 shows Complete button P12 a. WhenComplete button P12 a is pressed, display unit 131 displays screen P13.

Screen P13 shows a picture and an instruction on how to insert paper inthe printer and close the door. Also, screen P13 shows Complete buttonP13 a. When Complete button P13 a is pressed, display unit 131 displaysscreen P14. Thus, print unit 135 starts test printing.

When the test printing finishes, display unit 131 displays screen P15 asillustrated in FIG. 10. Screen P15 shows a question asking whether ornot the test printing has been correctly done, Yes button P15 a, and Nobutton P15 b. When No button P15 b is pressed, display unit 131 displaysscreen P16. When Yes button P15 a is pressed, display unit 131 displaysscreen P18.

Screen P16 shows Call TAC button P16 a and Continue button P16 b. WhenCall TAC button P16 a is pressed, display unit 131 displays screen P17.When Continue button P16 b is pressed, display unit 131 again displaysscreen P11 (see FIG. 9).

Screen P17 shows error details. If the user telephones to the TAC andcommunicates the description of screen P17, he/she can receive supportsmoothly. Screen P17 shows Return button P17 a. When Return button P17 ais pressed, display unit 131 displays screen P16.

Display unit 131 displays screen P18 and print unit 135 starts printingheader information. When the printing of the header informationfinishes, display unit 131 displays screen P19, as illustrated in FIG.11. Screen P19 shows a question asking whether or not the headerinformation is correct, Yes button P19 a, and No button P19 b. When Nobutton P19 b is pressed, display unit 131 displays screen P20. When Yesbutton P19 a is pressed, printer confirmation stops being displayed.Then, the screen proceeds to a screen of barcode reader conformation.

Screen P20 shows a description on update of header information andContinue button P20 a. When Continue button P20 a is pressed, displayunit 131 displays screen P21. Screen P21 shows Continue button P21 a.When Continue button P21 a is pressed, screen P22 is displayed, asillustrated in FIG. 12.

Screen P22 shows a description on data download. Then, display unit 131displays screen P23. It is to be noted that if screen P22 is repeatedthree times, display unit 131 displays screen P19 (see FIG. 11). ScreenP23 shows Call TAC button P23 a and Continue button P23 b. When Call TACbutton P23 a is pressed, display unit 131 displays screen P24. WhenContinue button P23 b is pressed, display unit 131 again displays screenP21 (see FIG. 11).

Screen P24 shows error details. If the user telephones to the TAC andcommunicates the description of screen P24, he/she can receive supportsmoothly. Screen P24 shows Return button P24 a. When Return button P24 ais pressed, display unit 131 displays screen P23.

(Display Example at Barcode Reader Confirmation)

With reference to FIG. 13, a display example at barcode readerconfirmation is described.

Specimen analyzer 100 can input information on a reagent as a consumableand on CELLCLEAN for cleaning only through a barcode reader asinformation read unit 150. To be more specific, it is necessary tocorrectly attach a barcode reader to specimen analyzer 100.

As barcode reader confirmation, display unit 131 displays screen P31, asillustrated in FIG. 13. Screen P31 shows a picture of the barcodereader, a question asking whether or not the barcode reader gives offred light when the button is pressed, Yes button P31 a, and No buttonP31 b. When No button P31 b is pressed, display unit 131 displays screenP32. When Yes button P31 a is pressed, display unit 131 displays screenP36.

Screen P32 shows a picture instructing to connect the barcode reader, aquestion asking whether or not the barcode reader is connected tospecimen analyzer 100, Yes button P32 a, and No button P32 b. When Nobutton P32 b is pressed, display unit 131 displays screen P33. When Yesbutton P32 a is pressed, display unit 131 displays screen P34. ScreenP33 shows a picture and an instruction on how to connect the barcodereader. Also, screen P33 shows Complete button P33 a. When Completebutton P33 a is pressed, display unit 131 displays screen P31.

Screen P34 shows a description on a problem with the barcode reader andCall TAC button P34 a. When Call TAC button P34 a is pressed, displayunit 131 displays screen P35. Screen P35 shows Return button P35 a. WhenReturn button P35 a is pressed, display unit 131 displays screen P34.

Screen P36 shows a picture and an instruction on how to read the barcodeof the Quick Guide using the barcode reader. When the barcode readercompletes reading the barcode of the Quick Guide, display unit 131displays screen P37. Screen P37 shows Continue button P37 a. WhenContinue button P37 a is pressed, the screen of barcode readerconfirmation finishes being displayed. Then, the screen proceeds to ascreen of the connection of various types of tubes.

(Display Example at Connection of Various Types of Tubes)

With reference to FIG. 14, a display example at the connection ofvarious types of tubes is described.

Display unit 131 displays screen P41 in order to connect various typesof tubes to specimen analyzer 100, as illustrated in FIG. 14. Screen P41shows a picture and an instruction on how to connect various types oftubes to specimen analyzer 100. Also, screen P41 shows Complete buttonP41 a. When Complete button P41 a is pressed, display unit 131 displaysscreen P42. Screen P42 shows instructions to place a reagent container,a waste liquid container etc. to be connected to tubes next to specimenanalyzer 100. Also, screen P42 shows Complete button P42 a. WhenComplete button P42 a is pressed, display unit 131 displays screen P43.

Screen P43 shows a picture and an instruction on how to connect thewaste liquid container. Also, screen P43 shows Complete button P43 a.When Complete button P43 a is pressed, display unit 131 displays screenP44. Finally, the screen on connecting various types of tubes finishesbeing displayed. Then, the screen proceeds to a screen of reagentsetting.

(Display Example when Setting Reagent)

With reference to FIG. 15 to FIG. 21, a display example when setting areagent is described.

Display unit 131 displays screen P51 in order to set a reagent, asillustrated in FIG. 15. Screen P51 shows a picture and an instruction onhow to set a container of a diluted solution used to analyze a specimen.Also, screen P51 shows Complete button P51 a. When Complete button P51 ais pressed, display unit 131 displays screen P52. Screen P52 shows apicture and an instruction on how to read a barcode attached on thecontainer of the diluted solution. When the barcode is correctly read,display unit 131 displays screen P53. If a barcode is invalid, includingthe case where the expiration date has passed, display unit 131 displaysscreen P54 (see FIG. 16). If the barcode does not match, display unit131 displays screen P55 (see FIG. 16).

While screen P53 is being displayed, connection is established to server200, and whether or not the reagent can be used is checked. Thereafter,display unit 131 displays screen P57 (see FIG. 17).

As illustrated in FIG. 16, screen P54 shows a description that thereagent of the read barcode is invalid. Also, screen P54 shows Continuebutton P54 a. When Continue button P54 a is pressed, display unit 131displays screen P51 (see FIG. 15).

Screen P55 shows a description that there is a problem with theconnection. Also, screen P55 shows Call TAC button P55 a and Continuebutton P55 b. When Call TAC button P55 a is pressed, display unit 131displays screen P56. When Continue button P55 b is pressed, display unit131 displays screen P51 (see FIG. 15). Screen P56 shows error details.If the user telephones to the TAC and communicates the description ofscreen P56, he/she can receive support smoothly. Screen P56 shows Returnbutton P56 a. When Return button P56 a is pressed, display unit 131displays screen P55.

As illustrated in FIG. 17, screen P57 shows a picture and an instructionon how to place the reagent container. Also, screen P57 shows Completebutton P57 a. When Complete button P57 a is pressed, display unit 131displays screen P58. Screen P58 shows a description to connect thereagent container and the tube together. Also, screen P58 shows Completebutton P58 a. When Complete button P58 a is pressed, display unit 131displays screen P59. Thereafter, as illustrated in FIG. 18, display unit131 displays screen P60.

Screen P60 shows a picture and an instruction on how to set a containerof a hemolyzer used to analyze a specimen. Also, screen P60 showsComplete button P60 a. When Complete button P60 a is pressed, displayunit 131 displays screen P61. Screen P61 shows a picture and aninstruction on how to read a barcode attached on the container of thehemolyzer. When the barcode is correctly read, display unit 131 displaysscreen P62. If a barcode is invalid, including the case where theexpiration date has passed, display unit 131 displays screen P63 (seeFIG. 19). If the barcode does not match, display unit 131 displaysscreen P64 (see FIG. 19).

While screen P62 is being displayed, connection is established to server200, and whether or not the reagent can be used is checked. Thereafter,display unit 131 displays screen P66 (see FIG. 20).

As illustrated in FIG. 19, screen P63 shows a description that thereagent of the read barcode is invalid. Also, screen P63 shows Continuebutton P63 a. When Continue button P63 a is pressed, display unit 131displays screen P60 (see FIG. 18).

Screen P64 shows a description that there is a problem with theconnection. Also, screen P64 shows Call TAC button P64 a and Continuebutton P64 b. When Call TAC button P64 a is pressed, display unit 131displays screen P65. When Continue button P64 b is pressed, display unit131 displays screen P60 (see FIG. 18). Screen P65 shows error details.If the user telephones to the TAC and communicates the description ofscreen P65, he/she can receive support smoothly. Screen P65 shows Returnbutton P65 a. When Return button P65 a is pressed, display unit 131displays screen P64.

As illustrated in FIG. 20, screen P66 shows a picture and an instructionon how to place the reagent container. Also, screen P66 shows Completebutton P66 a. When Complete button P66 a is pressed, display unit 131displays screen P67. Screen P67 shows a description to connect thereagent container and the tube together. Also, screen P67 shows Completebutton P67 a. When Complete button P67 a is pressed, display unit 131displays screen P68. Thereafter, display unit 131 displays screen P69.

Subsequently, display unit 131 displays screen P70. In addition, thediluted solution is fed to specimen analyzer 100. Thereafter, displayunit 131 displays screen P71. Moreover, the hemolyzer is fed to specimenanalyzer 100. Thereafter, display unit 131 displays screen P72. Finally,the screen of setting the reagent finished being displayed. Then, thescreen proceeds to a screen of cleaning by CELLCLEAN.

(Display Example of Cleaning by CELLCLEAN)

With reference to FIG. 22 to FIG. 25, a display example of cleaning byCELLCLEAN is described.

As illustrated in FIG. 22, display unit 131 displays screen P81 in orderto indicate the necessity of cleaning by CELLCLEAN. Screen P81 showsContinue button P81 a. When Continue button P81 a is pressed, displayunit 131 displays screen P82. Screen P82 shows a picture and aninstruction on CELLCLEAN to be used. Also, screen P82 shows Completebutton P82 a. When Complete button P82 a is pressed, display unit 131displays screen P83.

Screen P83 shows a picture and an instruction on how to open a door andinsert an adapter. Also, screen P83 shows Complete button P83 a. WhenComplete button P83 a is pressed, display unit 131 displays screen P84.Screen P84 shows a description to read a barcode attached on thecontainer of CELLCLEAN. Also, screen P84 shows Quit button P84 a. Whenthe barcode is correctly read, display unit 131 displays screen P89 (seeFIG. 24). In the case where the expiration date has passed, display unit131 displays screen P85 (see FIG. 23). If the barcode does not match,display unit 131 displays screen P87 (see FIG. 23). When Quit button P84a is pressed, display unit 131 displays screen P91 (see FIG. 24).

Screen P85 shows a description that there is a problem with theconnection. Also, screen P85 shows Call TAC button P85 a and Continuebutton P85 b. When Call TAC button P85 a is pressed, display unit 131displays screen P86. When Continue button P85 b is pressed, display unit131 displays screen P84 (see FIG. 22). Screen P86 shows error details.If the user telephones to the TAC and communicates the description ofscreen P86, he/she can receive support smoothly. Screen P86 shows Returnbutton P86 a. When Return button P86 a is pressed, display unit 131displays screen P85.

Screen P87 shows a description that CELLCLEAN is invalid. Also, screenP87 shows Call TAC button P87 a, Continue button P87 b, and Quit buttonP87 c. When Call TAC button P87 a is pressed, display unit 131 displaysscreen P88. When Continue button P87 b or Quit button P87 c is pressed,display unit 131 displays screen P84 (see FIG. 22). Screen P88 showserror details. If the user telephones to the TAC and communicates thedescription of screen P88, he/she can receive support smoothly. ScreenP88 shows Return button P88 a. When Return button P88 a is pressed,display unit 131 displays screen P87.

As illustrated in FIG. 24, screen P89 shows a description on validationand download of CELLCLEAN information. Thereafter, display unit 131displays screen P90. Screen P90 shows a picture and an instruction onhow to place CELLCLEAN. After CELLCLEAN is placed and the door isclosed, display unit 131 displays screen P94 (see FIG. 25).

Screen P91 shows a description that the adapter is set and Continuebutton P91 a. When Continue button P91 a is pressed, display unit 131displays screen P92. Screen P92 shows a picture and an instruction onhow to remove the adapter. Also, screen P92 shows Complete button P92 a.When Complete button P92 a is pressed, display unit 131 displays screenP93. Screen P93 shows a picture and an instruction on how to close thedoor. Also, screen P93 shows Complete button P93 a. When Complete buttonP93 a is pressed, display unit 131 displays screen P91.

As illustrated in FIG. 25, display unit 131 displays screen P94. Also,CELLCLEAN cleans the inside of specimen analyzer 100. Thereafter,display unit 131 displays screen P95. Screen P95 shows a picture and aninstruction on how to remove the container of CELLCLEAN from specimenanalyzer 100. Also, screen P95 shows Complete button P95 a. WhenComplete button P95 a is pressed, display unit 131 shows screen P96.

Screen P96 shows a description to prepare specimen analyzer 100 andContinue button P96 a. When Continue button P96 a is pressed, displayunit 131 displays screen P97. Also, the preparation of specimen analyzer100 proceeds. Finally, the screen of cleaning by CELLCLEAN finishesbeing displayed. Then, the screen proceeds to a screen of QCmeasurement.

(Display Example at QC Measurement)

With reference to FIG. 26 to FIG. 32, a display example at QCmeasurement is described.

As illustrated in FIG. 26, display unit 131 displays screen P101 inorder to indicate the necessity of QC (Quality Control) measurement.Screen P101 shows Continue button P101 a. When Continue button P101 a ispressed, display unit 131 displays screen P102. Screen P102 shows apicture and an instruction on how to open the door and insert theadapter. Also, screen P102 shows Complete button P102 a. When Completebutton P102 a is pressed, display unit 131 displays screen P103.

Screen P103 shows a description to input the ID of the operator. Also,screen P103 shows Complete button P103 a, Quit button P103 b, inputbuttons P103 c, and input region P103 d. When input buttons P103 c areoperated, input region P103 d displays inputted characters. The ID ofthe operator can be set using, for example, any one to threealphabetical letters. Also, the ID of the operator may be different foreach of the High, Low, and Normal QC reagents.

When Complete button P103 a is pressed, display unit 131 displays screenP104. In the example of FIG. 26, the string “MJT” is inputted as the IDof the operator. Screen P104 shows Complete button P104 a, Quit buttonP104 b, input buttons P104 c, and input region P104 d. When the pressingof Complete button P104 a succeeds, display unit 131 displays screenP106 (see FIG. 27). When Complete button P104 a is pressed but the inputis NG, display unit 131 displays screen P105.

Screen P105 shows a description that the operator ID is invalid,Continue button P105 a, and Quit button P105 b. When Continue buttonP105 a is pressed, display unit 131 displays screen P103.

As illustrated in FIG. 27, screen P106 shows a question asking whetheror not the operator ID is correct, Yes button P106 a and No button P106b, and Quit button P106 c. When No button P106 b is pressed, displayunit 131 displays screen P103. When Yes button P106 a is pressed,display unit 131 displays screen P107.

Screen P107 shows a picture and an instruction on how to read a barcodeof a High QC reagent. Also, screen P107 shows Quit button P107 a. Whenthe barcode of the QC reagent is read, display unit 131 displays screenP108. Screen P108 shows a description on validation and download ofinformation on the QC reagent. Once information on the QC reagent isdownloaded from server 200, a range of normal value of the measurementvalue of the QC reagent is obtained.

When the validation and download of information on the QC reagentsucceed, display unit 131 displays screen P112 (see FIG. 29). When theQC reagent is determined as invalid, display unit 131 displays screenP109 (see FIG. 28). When the QC reagent is determined as a scanned QCreagent, display unit 131 displays screen P111 (see FIG. 28).

As illustrated in FIG. 28, screen P109 shows a description that the QCreagent is invalid. Also, screen P109 shows Call TAC button P109 a,Continue button P109 b, and Quit button P109 c. When Call TAC buttonP109 a is pressed, display unit 131 displays screen P110. When Continuebutton P109 b is pressed, display unit 131 displays screen P108 (seeFIG. 27). Screen P110 shows error details. If the user telephones to theTAC and communicates the description of screen P110, he/she can receivesupport smoothly. Screen P110 shows Return button P110 a. When Returnbutton P110 a is pressed, display unit 131 displays screen P109.

Screen P111 shows a description that the QC reagent is invalid. Also,screen P111 shows Continue button P111 a and Quit button P111 b. WhenContinue button P111 a is pressed, display unit 131 displays screen P108(see FIG. 27).

As illustrated in FIG. 29, screen P112 shows a description to startagitating the QC reagent, Continue button P112 a, and Quit button P112b. When Continue button P112 a is pressed, display unit 131 displaysscreen P113. Screen P113 shows a description to agitate the QC reagent,Quit button P113 a, and timer P113 b. Timer P113 b is displayed countingdown from 15 sec, for example. When the time counted down by timer P113b has elapsed, display unit 131 displays screen P114.

Screen P114 shows Complete button P114 a and Quit button P114 b. WhenComplete button P114 a is pressed, display unit 131 displays screenP115. Screen P115 shows a picture and an instruction on how to set theQC reagent. Also, screen P115 shows Quit button P115 a.

When the QC reagent is set and the door is closed, display unit 131displays screen P116, as illustrated in FIG. 30. Also, measurement of QCreagent is performed. When the treatment of the QC reagent fails,display unit 131 displays screen P117. Screen P117 shows a descriptionto perform measurement again. Also, screen P117 shows Continue buttonP117 a. When Continue button P117 a is pressed, display unit 131displays screen P120. When the measurement of the QC reagent finishesnormally, display unit 131 displays screen P118. Screen P118 showsContinue button P118 a. When Continue button P118 a is pressed, displayunit 131 displays screen P120.

Here, display unit 131 displays screen P119 when the Quit button ispressed in any of the screens, or when a predetermined time period haselapsed with the screen left unoperated. Screen P119 shows Continuebutton P119 a. When Continue button P119 a is pressed, display unit 131displays screen P120.

Screen P120 shows a picture and an instruction on how to remove thecontainer of the QC reagent from specimen analyzer 100. Also, screenP120 shows Complete button P120 a. When Complete button P120 a ispressed, display unit 131 displays screen P121 (see FIG. 31).

As illustrated in FIG. 31, screen P121 shows a picture and aninstruction on how to remove the adapter from specimen analyzer 100. Inaddition, screen P121 shows Complete button P121 a. When Complete buttonP121 a is pressed, display unit 131 displays screen P122. Screen P122shows a picture and an instruction on how to close the door. Also,screen P122 shows Complete button P122 a. When Complete button P122 a ispressed, the measurement process of the High QC reagent finishes.Thereafter, a measurement process of a Low QC reagent is performed.

If the QC adapter is remaining when Complete button P122 a is pressed,display unit 131 displays screen P123. Screen P123 shows Continue buttonP123 a. When Continue button P123 a is pressed, display unit 131displays screen P121.

When the measurement process of the Low QC reagent starts, display unit131 displays screens similar to screens P101 to P106, and similarprocesses are performed. Thereafter, display unit 131 displays screenP124. Screen P124 displays a picture and an instruction on how to read abarcode of the Low QC reagent. Also, screen P124 shows Quit button P124a. When the barcode of the QC reagent is read, display unit 131 displaysscreens similar to screen P108 to P123, and similar processes areperformed. Finally, the measurement process of the Low QC reagentfinishes. Thereafter, a measurement process of a Normal QC reagent isperformed.

When the measurement process of the Normal QC reagent starts, displayunit 131 displays screens similar to screen P101 to P106, and similarprocesses are performed. Thereafter, display unit 131 displays screenP125. Screen P125 displays a picture and an instruction on how to read abarcode of the Normal QC reagent. Also, screen P125 shows Quit buttonP125 a. When the barcode of the QC reagent is read, display unit 131displays screens similar to screen P108 to P123, and similar processesare performed. Finally, the measurement process of the Normal QC reagentfinishes. Then, the screen of QC measurement stops being displayed.Subsequently, the screen proceeds to a screen of sample measurement.Thus, the preparation for sample measurement is done.

(Display Example at Sample Measurement)

With reference to FIG. 33 to FIG. 40, display example at samplemeasurement is described.

As illustrated in FIG. 33, display unit 131 displays screen P131 formeasuring the sample of the patient as the specimen. In the case ofwaiting for preparation of sample measurement, display unit 131 displaysscreen P131. Screen P131 shows Standard Tube button P131 a and arrowbutton P131 b. When arrow button P131 b is pressed, display unit 131displays screen P160 for maintenance (see FIG. 41). When Standard Tubebutton P131 a is pressed, display unit 131 displays screen P132. ScreenP132 shows a question asking whether or not the sample container iscorrect, Yes button P132 a and No button P132 b, and Quit button P132 c.When No button P132 b or Quit button P132 c is pressed, display unit 131displays screen P131. When Yes button P132 a is pressed, display unit131 displays screen P133.

Screen P133 shows a picture and an instruction on how to open the doorand insert the adapter. Also, screen P133 shows Complete button P133 aand Quit button P133 b. When Complete button P133 a is pressed, displayunit 131 displays screen P134 (see FIG. 34).

As illustrated in FIG. 34, screen P134 shows a description for inputtingthe ID of the operator. Also, screen P134 shows Complete button P134 a,Quit button P134 b, input buttons P134 c, and input region P134 d. Wheninput buttons P134 c are operated, input region P134 d displays inputtedcharacters. The ID of the operator can be set using, for example, anyone to three alphabetical letters.

When Complete button P134 a is pressed, display unit 131 displays screenP135. In the example of FIG. 34, the string “MJT” is inputted as the IDof the operator. Screen P135 shows Complete button P135 a, Quit buttonP135 b, input buttons P135 c, and input region P135 d. When Completebutton P135 a is pressed and the input is OK, display unit 131 displaysscreen P137. When Complete button P135 a is pressed but the input is NG,display unit 131 displays screen P136.

Screen P136 shows a description that the operator ID is invalid,Continue button P136 a, and Quit button P136 b. When Continue buttonP136 a is pressed, display unit 131 displays screen P134.

Screen P137 shows a question asking whether or not the operator ID iscorrect, Yes button P137 a and No button P137 b, and Quit button P137 c.When No button P137 b is pressed, display unit 131 displays screen P134.When Yes button P137 a is pressed, display unit 131 displays screen P138(see FIG. 35).

As illustrated in FIG. 35, screen P138 shows a description for inputtingthe ID of the operator. Also, screen P138 shows Complete button P138 a,Quit button P138 b, input buttons P138 c, and input region P138 d. Wheninput buttons P138 c are operated, input region P138 d displays inputtedcharacters. The ID of the patient can be set using, for example, anyfour or more characters. The ID of the patient can be set using four tonine characters. Also, the ID of the patient can include zero to twoalphabetical letters. In addition, the ID of the patient can includenumbers from zero to eight characters.

When Complete button P138 a is pressed, display unit 131 displays screenP139. In the example of FIG. 35, the string “1234” is inputted as the IDof the patient. Screen P139 shows Complete button P139 a, Quit buttonP139 b, input buttons P139 c, and input region P139 d. When Completebutton P139 a is pressed and the input is OK, display unit 131 displaysscreen P141. When Complete button P139 a is pressed but the input is NG,display unit 131 displays screen P140.

Screen P140 shows a description that the patient ID is invalid, Continuebutton P140 a, and Quit button P140 b. When Continue button P140 a ispressed, display unit 131 displays screen P138.

Screen P141 shows a question asking whether or not patient ID iscorrect, Yes button P141 a and No button P141 b, and Quit button P141 c.When No button P141 b is pressed, display unit 131 displays screen P138.When Yes button P141 a is pressed, display unit 131 displays screen P142(see FIG. 36).

As illustrated in FIG. 36, screen P142 shows a description for inputtingthe date of birth of the patient. Also, screen P142 shows Completebutton P142 a, Quit button P142 b, input buttons P142 c, and inputregion P142 d. When input buttons P142 c are operated, input region P142d displays inputted characters.

When Complete button P142 a is pressed, display unit 131 displays screenP143. In the example of FIG. 36, “11/11/2000” is inputted as the date ofbirth of the patient. Screen P143 shows Complete button P143 a, Quitbutton P143 b, input buttons P143 c, and input region P143 d. When theComplete button P143 a is pressed and the input is OK, display unit 131displays screen P145. When Complete button P143 a is pressed but theinput is NG, display unit 131 displays screen P144.

Screen P144 shows a description that the date of birth of the patient isinvalid, Continue button P144 a, and Quit button P144 b. When Continuebutton P144 a is pressed, display unit 131 displays screen P142.

Screen P145 shows a question asking whether or not the date of birth ofthe patient is correct, Yes button P145 a and No button P145 b, and Quitbutton P145 c. When No button P145 b is pressed, display unit 131displays screen P142. When Yes button P145 a is pressed, display unit131 displays screen P146 (see FIG. 37).

As illustrated in FIG. 37, screen P146 shows a question asking whetheror not the sample container is cold, Yes button P146 a and No buttonP146 b, and Quit button P146 c. When Yes button P146 a is pressed,display unit 131 displays screen P147. Screen P147 shows a picture andan instruction on how to warm the sample container. Also, screen P147shows Complete button P147 a and Quit button P147 b. When Completebutton P147 a is pressed, display unit 131 displays screen P148.

Screen P148 shows a description to start agitating the sample, Continuebutton P148 a, and Quit button P148 b. When Continue button P148 a ispressed, display unit 131 displays screen P149 (see FIG. 38).

As illustrated in FIG. 38, screen P149 shows a description to agitatethe sample, Quit button P149 a, and timer P149 b. Timer P149 b isdisplayed counting down from 15 sec, for example. When the time counteddown by timer P149 b has elapsed, display unit 131 displays screen P150.Screen P150 shows Complete button P150 a and Quit button P150 b. WhenComplete button P150 a is pressed, display unit 131 displays screenP152.

Here, display unit 131 displays screen P151 when the Quit button ispressed in any of the screens, or when a predetermined time period haselapsed with the screen left unoperated. Screen P151 shows Continuebutton P151 a. When Continue button P151 a is pressed, display unit 131shows screen P152.

Screen P152 shows a picture and an instruction on how to set the samplecontainer. Also, screen P152 shows Quit button P152 a.

When the sample container is set and the door is closed, display unit131 displays screen P153, as illustrated in FIG. 39. Also, measurementof sample is performed. When the measurement of the sample finishes,display unit 131 displays screen P154. Screen P154 shows a descriptionfor printing and Continue button P154 a. When Continue button P154 a ispressed, display unit 131 displays screen P155.

Screen P155 shows a description that the printing is in progress. Also,print unit 135 prints the results. If one or more of the measurementresults are outside normal range, display unit 131 displays screen P156.Screen P156 shows a description to perform measurement again, Continuebutton P156 a, and Quit button P156 b. When Continue button P156 a ispressed, display unit 131 displays first screen P131 of samplemeasurement (see FIG. 33).

As illustrated in FIG. 40, screen P157 shows a picture and aninstruction on how to remove the sample container from specimen analyzer100. Also, screen P157 shows Complete button P157 a. When Completebutton P157 a is pressed, display unit 131 displays screen P158. ScreenP158 shows a picture and an instruction on how to close the door. Also,screen P158 shows Complete button P158 a. When Complete button P158 a ispressed, the sample measurement process finishes. Thereafter, displayunit 131 displays first screen P131 of sample measurement (see FIG. 33).

If the adapter is remaining when Complete button P158 a is pressed,display unit 131 displays screen P159. Screen P159 shows Continue buttonP159 a. When Continue button P159 a is pressed, display unit 131displays screen P157.

In this way, in the example of FIG. 40, display unit 131 displays printoperation screen (see screen P154) for starting of the printing ofanalysis results 102.

In print operation screen P154, display unit 131 displays operationalguidance and instructions to deal with printed sheet after printing[0179] The instructions to deal with the printed sheet include a messageinstructing to deliver the printed sheet to the ordering doctor. As anexplanation for the printing, screen P154 shows an example ofoperational guidance teaching to input Continue button P154 a, and ofdelivering the printed sheet to the ordering doctor or the like.

Print unit 135 starts the printing of analysis results 102 based on theoperations in accordance with print operation screen P154 (see screenP155). To be more specific, print unit 135 starts the printing ofanalysis results 102 based on the input of Continue button P154 a.

Also, in the example of FIG. 39 and the example of FIG. 40, analysisunit 120 is capable of analyzing next specimen 101 if an operation isperformed in accordance with the print operation screen. To be morespecific, if a series of operations up to screen P158 including anoperation on screen P154 completes, controller 140 causes display unit131 to display P131 (see FIG. 33) to be ready for an analysis of nextspecimen 101.

In addition, if analysis results 102 include an abnormal value,controller 140 causes display unit 131 to display an abnormal valuenotification screen (see screen P156) to communicate that an abnormalvalue is included. When abnormal value notification screen P156 isdisplayed, analysis unit 120 is capable of retesting same specimen 101when an operation is performed in accordance with abnormal valuenotification screen P156.

If analysis results 102 include an abnormal value, controller 140prohibits print unit 135 from printing analysis results 102, and causesabnormal value notification screen P156 to show a message prompting toperform retesting. The example of screen P156 shows a messagecommunicating it is necessary to retest because one or more analysisresults 102 are outside normal range.

In the example of screen P156, when Continue button 156 a is inputted, aseries of processes for performing retest are executed. Here, byinputting Quit button 156 b, analysis of another specimen 101 can bestarted.

(Display Example at Maintenance)

With reference to FIG. 41 to FIG. 48, a display example at maintenanceis described.

As illustrated in FIG. 41, screen P160 shows a screen for performingmaintenance. To be more specific, screen P160 Quit button P160 a, AutoRince button P160 b, Remove Clog button P160 c, Replace Pack-D buttonP160 d, Replace Pack-L button P160 e, Preventive MaintP button P160 f,Past Results button P160 g, and Move Instrument button P160 h.

When Auto Rince button P160 b is pressed, display unit 131 displaysscreen P161, as illustrated in FIG. 42. Also, a cleaning process withuse of a diluted solution is performed. Thereafter, display unit 131displays first screen P131 of sample measurement (see FIG. 33).

When Remove Clog button P160 c is pressed, display unit 131 displaysscreen P162, as illustrated in FIG. 43. Also, a process of removing theclog of detector 123 is performed.

When Replace Pack-D button P160 d is pressed, display unit 131 displaysscreen P171, as illustrated in FIG. 44. In addition, display unit 131displays screen P171 also in the case where it is determined that thediluted solution has been used up. Screen P171 displays Continue buttonP171 a. When Continue button P171 a is pressed, display unit 131displays screens similar to screens P51 and P52, and similar processesare performed. Thereafter, display unit 131 displays screen P172.

Screen P172 shows a picture and an instruction on how to place thereagent container. Also, screen P172 shows Complete button P172 a. WhenComplete button P172 a is pressed, display unit 131 displays screenP173. Screen P173 shows a description for replacing the reagentcontainer. Also, screen P173 shows Complete button P173 a. When Completebutton P173 a is pressed, display unit 131 displays screen P174.

Screen P174 shows a description to place and dispose of the reagentcontainer. Also, screen P174 shows Complete button P174 a. When Completebutton P174 a is pressed, display unit 131 displays screen P175. Also,the diluted solution is fed to specimen analyzer 100. Thereafter,display unit 131 displays screen P176. After that, display unit 131displays first screen P131 of sample measurement (see FIG. 33).

When Replace Pack-L button P160 e is pressed, display unit 131 displaysscreen P181, as illustrated in FIG. 45. In addition, display unit 131displays screen P181 also in the case where it is determined that thehemolyzer has been used up. Screen P181 displays Continue button P181 a.When Continue button P181 a is pressed, display unit 131 displaysscreens similar to screens P51, P52, and P172 to P176, and similarprocesses are performed. Thereafter, display unit 131 displays firstscreen P131 of sample measurement (see FIG. 33).

When Preventive MaintP button P160 f is pressed, display unit 131displays screen P191, as illustrated in FIG. 46. Also, display unit 131displays screen P191 when cleaning by CELLCLEAN is needed. Screen P191shows Continue button P191 a. When Continue button P191 a is pressed, aprocess similar to the cleaning by CELLCLEAN is performed. Thereafter, aprocess similar to the QC measurement is performed, and display unit 131displays first screen P131 of sample measurement (see FIG. 33).

When Past Results button P160 g is pressed, display unit 131 displaysscreen P201, as illustrated in FIG. 47. Screen P201 shows Reprint buttonP201 a, Quit button P201 b, and select button P201 c. When select buttonP201 c is used to select a past measurement and Reprint button P201 a ispressed, past analysis results are printed. By pressing Reprint button201 a, display unit 131 displays screen P202. Then, print unit 135prints the analysis results. Thereafter, display unit 131 displays firstscreen P131 of sample measurement (see FIG. 33).

When Move Instrument button P160 h is pressed, display unit 131 displaysscreen P211, as illustrated in FIG. 48. Screen P211 shows Continuebutton P211 a. When Continue button P211 a is pressed, display unit 131displays screen P212. Screen P212 shows a picture and an instruction onhow to remove the Ethernet cable from specimen analyzer 100. Also,screen P212 shows Complete button P212 a. When Complete button P212 a ispressed, display unit 131 displays screen P213.

Screen P213 shows a picture and an instruction on how to remove thebarcode reader from specimen analyzer 100. Also, screen P213 showsComplete button P213 a. When Complete button P213 a is pressed, displayunit 131 displays screen P214. Screen P214 shows a picture and aninstruction on how to remove the container of the diluted solution fromthe tube. Also, screen P214 shows Complete button P214 a. When Completebutton P214 a is pressed, display unit 131 displays screen P215.

Screen P215 shows a picture and an instruction on how to remove thecontainer of the hemolyzer from the tube. Also, screen P215 showsComplete button P215 a. When Complete button P215 a is pressed, displayunit 131 displays screen P216. Screen P216 shows a description todischarge the liquid. In addition, the liquid is discharged fromspecimen analyzer 100. Thereafter, display unit 131 displays screenP217.

Screen P217 shows a picture and an instruction on how to remove thecontainer of the waste liquid from the tube. Also, screen P217 showsComplete button P217 a. When Complete button P217 a is pressed, displayunit 131 displays screen P218. Screen P218 shows a description thatshutdown is in progress. Thereafter, display unit 131 displays screenP219.

Screen P219 shows a picture and an instruction on how to power offspecimen analyzer 100. Thereafter, the user powers off.

(Outputting of Analysis Results)

In the example illustrated in FIG. 2, analysis unit 120 perform analysison seventeen analysis items in total, eight measurement items plus nineanalysis items, as described above. In this embodiment, controller 140performs control of causing print unit 135 to print analysis results102, and prohibiting display unit 131 from displaying analysis results102. Thus, as a result of analysis operations of specimen analyzer 100,the user obtains printed sheet 300 being print sheet 136 on whichanalysis results 102 are written, as illustrated in FIG. 49.

In the example of FIG. 49, printed on printed sheet 300 are facilityinformation 301, apparatus information 302, date information 303,operator information 304, subject information 305, subject attributeinformation 306, result displaying section 307, message section 308, andreference value information 309. Note that although printed sheet 300 isseparated for convenience in FIG. 49, the separated portions areactually connected, and printed sheet 300 is one piece of print sheet136 on which printing has been performed.

Facility information 301 includes information on the name and theaddress of the facility such as a hospital where specimen analyzer 100is installed.

Apparatus information 302 is information for identifying specimenanalyzer 100 which performed analysis. Apparatus information 302includes, for example, the model, the name, and the serial number of theapparatus.

Date information 303 is information for identifying the time point atwhich analysis was performed. Date information 303 includes the analysisdate. In FIG. 49, date information 303 includes the analysis time inaddition to the analysis date.

Operator information 304 is ID information for identifying the operatorwho operated specimen analyzer 100. Operator information 304 is notparticularly limited, and is represented by three alphabetical letters,for example.

Subject information 305 is ID information for identifying the subjectfrom which specimen 101 is collected. Subject information 305 isrepresented by a seven-digit number, for example.

Subject attribute information 306 is information on the subject fromwhich specimen 101 is collected, and shows the characteristics andnature of the subject. Preferable as subject attribute information 306is information useful for diagnosis based on analysis results 102.Subject attribute information 306 includes at least one of the date ofbirth, age, and sex, for example. It is possible to grasp the age of thesubject using the date of birth. Subject attribute information 306 maybe an age, or information on the corresponding one of the age sections.There is a case where the criteria for diagnosis based on analysisresults 102 differ depending on the sex, in addition to the age. Hence,subject attribute information 306 may include sex. Furthermore, subjectattribute information 306 may include body information such as theheight and the weight of the subject.

Result displaying section 307 is an area where analysis results 102 areprinted. Analysis results 102 include numerical information 102 a. Inaddition, if analysis results 102 include an error, analysis results 102include information 102 b indicating the type of the abnormality. Asillustrated in FIG. 49, regarding multiple analysis items, print unit135 prints analysis results 102 for each of the analysis items.Regarding each analysis item, one line of result displaying section 307is assigned one item. To be more specific, in each analysis item ofresult displaying section 307, the item name, numerical information 102a, and information 102 b indicating the type of the abnormality (flag)are displayed in sequential order from left.

Information 102 b indicating the type of the abnormality is printed tonotify the user of the type of the abnormality when one or more ofanalysis results 102 are outside normal range, or when there is apredetermined analysis result error. If analysis results 102 include anabnormal value, controller 140 prints information 102 b indicating thetype of the abnormality as analysis results 102. Determination as towhether or not the results are normal or erroneous is made based on thenumerical ranges for analysis result determination.

In the example of FIG. 50, for example, as information 102 b indicatingthe type of the abnormality, print unit 135 prints information 102 bindicating the type of the abnormality if analysis results 102 includesan abnormal value. Information 102 b indicating the content of the errorincludes information 314 indicating a first error showing that numericalinformation 102 a is included in a first erroneous ranges 372 (see FIG.53), and information 315 indicating a second error showing thatnumerical information 102 a is included in a second erroneous ranges 373(see FIG. 53). Information 314 indicating a first error can include anindicator indicating a high value (High) and an indicator indicating alow value (Low) for each of analysis results 102. Information 315indicating a second error can include an indicator indicating anerroneously high value (ALERT H) and an indicator indicating anerroneously low value (ALERT L), for example.

If a certain abnormal value included in analysis results 102 is within apreset predetermined numerical range, controller 140 excludes thepredetermined abnormal value in analysis result 102 from the content tobe printed. An embodiment of displaying result displaying section 307 isdescribed later.

In FIG. 49, displayed in message section 308 is a predetermined messageto the user in a predetermined case. The predetermined message includesmessage 311 prompting further testing. Furthermore, the predeterminedmessage includes, for example, message 312 recommending the user to actimmediately. If analysis results 102 have no particular problem, nomessage is displayed in message section 308.

The intention of reference value information 309 is to provideinformation for evaluating analysis results 102 to the user. Thus, inaddition to analysis results 102, print unit 135 prints reference valueinformation 309 to evaluate analysis results 102. Analysis result 102 ofeach analysis item has a numerical range considered a normal range.Reference value information 309 of FIG. 49 is information on numericalranges indicating normal ranges 371 of analysis results 102. Here, thenormal range for each analysis item differs depending on subjectattribute information 306 such as the age of the subject. In light ofthis, in FIG. 49, reference value information 309 possesses severaltypes depending on subject attribute information 306 on the subject fromwhich specimen 101 is collected. Print unit 135 prints: subjectattribute information 306: and reference value information 309corresponding to subject attribute information 306 out of several typesof reference value information 309.

As described above, in the example of FIG. 49, in addition to analysisresults 102, print unit 135 prints the analysis date, operatorinformation 304 on the operator who performed analysis, and subjectattribute information 306 on the subject from which the specimen iscollected.

The information above is printed on the same surface of a single pieceof print sheet 136. To be more specific, print unit 135 prints analysisresults 102, subject attribute information 306, reference valueinformation 309, and, if necessary, the predetermined message on thesame surface of a single piece of print sheet 136. In the example ofFIG. 49, all information to be printed is printed on the same surface ofa single piece of print sheet 136.

(Output Rules and Display Embodiment of Analysis Results on PrintedSheet)

Subsequently, output rules and a display embodiment in result displayingsection 307 of printed sheet 300 are described.

Controller 140 determines whether or not analysis results 102 can beoutputted depending on numerical information 102 a as analysis results102. If numerical information 102 a falls within a predetermined range,controller 140 prohibits outputting of numerical information 102 a toprinted sheet 300. Memory 142 of controller 140 stores data of numericalranges for analysis result determination (see FIG. 53 to FIG. 55)

<First Determination Ranges>

As illustrated in FIG. 51, out of numerical information 102 a asanalysis results 102 of analysis unit 120, controller 140 performscontrol of prohibiting the outputting of numerical information 102 aoutside first determination ranges relating to reliability of analysis.

FIG. 52 illustrates an example of first determination ranges 350. Firstdetermination ranges 350 (see FIG. 52) are each a numerical rangeconsidered reliable enough for analysis itself by analysis unit 120.First determination ranges 350 are each a numerical range which surelyhas reproducibility, accuracy, linearity, etc. of analysis results 102of specimen analyzer 100 within a predetermined range, and is anumerical range set as the specifications of specimen analyzer 100.

In the example of FIG. 52, first determination ranges 350 are each alinearity guarantee range for specimen analyzer 100. To be morespecific, analysis unit 120 outputs analysis results proportional to thenumber and the concentration of the target components in specimen 101.Here, the linearity guarantee range is a range where the analysisresults match the line of proportionality within a predetermined errorrange. In other words, the linearity guarantee range may be referred toas a measurable range for analysis unit 120. Out of the analysis items,first determination ranges 350 are set for five measurement items, WBC,RBC, HGB, HCT, and PLT, which are measured by detector 123. Regardingthe measurement items, when numerical information 102 a outside thenumerical ranges illustrated in FIG. 52 is obtained as analysis results102, controller 140 prohibits the outputting of numerical information102 a as a measurement error.

In the example of FIG. 51, even in the case of numerical information 102a within first determination ranges 350, controller 140 performs controlof prohibiting outputting when numerical information 102 a includes apredetermined abnormal value. Regarding numerical information 102 awithin first determination ranges 350, controller 140 prohibitsoutputting when the information is within second determination ranges360 indicating a predetermined error of the specimen, and performscontrol of permitting outputting when the information is outside seconddetermination ranges 360.

First, regarding numerical information 102 a within first determinationranges 350, analysis unit 120 performs analysis based on the numericalranges for analysis result determination illustrated in FIG. 53 to FIG.55. To be more specific, first determination ranges 350 include normalranges (reference ranges) 371 indicating normal values, first erroneousranges 372 wider than corresponding normal ranges 371, and seconderroneous ranges 373 wider than first erroneous ranges 372. In thisembodiment, second determination ranges 360 are set as second erroneousranges 373.

<Normal Range>

Controller 140 outputs analysis results 102 included in normal ranges371 illustrated in FIG. 53 to FIG. 55. In the example of printed sheet300 illustrated in FIG. 50, for instance, the value of MCH (29.8 [pg])falls within the normal range of an adult (see FIG. 55), and numericalinformation 102 a is printed as it is. If analysis results 102 areincluded in normal ranges 371, this means there is no error. Thus,information 102 b indicating the type of the abnormality for theanalysis items is not printed.

As illustrated in FIG. 53 to FIG. 55, first erroneous ranges 372 includeranges of low value (Low) and ranges of high value (High). Seconderroneous ranges 373 include ranges of erroneously low value (ALERT LOW)and ranges of erroneously high value (ALERT HIGH). To be more specific,first erroneous ranges 372 are ranges indicating minor errors nearnormal ranges 371, and second erroneous ranges 373 are ranges indicatingsignificant errors further deviating from first erroneous ranges 372.

<First Erroneous Range>

In the example of FIG. 51, in the initial test, controller 140 prohibitsthe outputting of printed sheet 300 if numerical information 102 a isincluded in first erroneous ranges 372. To be more specific, ifnumerical information 102 a is included in first erroneous ranges 372,controller 140 does not output printed sheet 300 but causes the user toperform retest on same specimen 101 using abnormal value notificationscreen P156 for notifying that an abnormal value is included. Thus, inthe initial test, all analysis results 102 are prohibited from beingoutputted if numerical information 102 a is included in first erroneousranges 372.

Controller 140 causes printed sheet 300 to output analysis results 102obtained in retest. If initial analysis results 102 match retestedanalysis results 102, controller 140 causes print unit 135 to printanalysis results 102, and if initial analysis results 102 do not matchretested analysis results 102, controller 140 prohibits the printing ofmismatched analysis results 102. To be more specific, if numericalinformation 102 a of retest is included in first erroneous ranges 372and if determination results of numerical information 102 a match thoseof the initial test, controller 140 permits the outputting of thatnumerical information 102 a, and outputs information indicating the typeof the abnormality. For example, if numerical information 102 a of theinitial test is included in the range of “Low” and if numericalinformation 102 a of retest is included in the range of “Low” as well,the controller outputs information 314 indicating a first error wherenumerical information 102 a is included in first erroneous ranges 372,together with numerical information 102 a.

In the example of printed sheet 300 illustrated in FIG. 50, the value ofMCV (81.6 [fL]) corresponds to a low value (see FIG. 55) of an adult,and “Low” information 314 indicating a first error is printed togetherwith analysis results. Note that if the analysis result corresponds to ahigh value, “High” is printed as information 314 indicating a firsterror.

If numerical information 102 a of retest is included in first erroneousranges 372 and if determination results of numerical information 102 ado not match those of the initial test, controller 140 prohibits theoutputting of that numerical information 102 a, and outputs informationindicating the type of the abnormality. For example, if numericalinformation 102 a of the initial test is included in the range of “Low”and if numerical information 102 a of retest is included in the range of“High,” the controller prohibits the outputting of numerical information102 a. In this case, as the analysis items, information 314 indicating afirst error is printed.

<Second Erroneous Range>

In the example of FIG. 51, out of numerical information 102 a includedin second erroneous ranges 373, controller 140 prohibits the outputtingof numerical information 102 a within second determination ranges 360,and permits the outputting of numerical information 102 a outside seconddetermination ranges 360. If numerical information 102 a is included insecond erroneous ranges 373, controller 140 outputs information 102 bindicating the type of the abnormality. To be more specific, as has beenillustrated in FIG. 50, controller 140 displays an indicator indicatingan erroneously high value (ALERT H) or an indicator indicating anerroneously low value (ALERT L) as information 315 indicating a seconderror where numerical information 102 a is included in second erroneousranges 373.

Second determination ranges 360 are each a range of abnormal valuepresenting the possibility of having a predetermined serious disease.Possible predetermined serious diseases in the blood cell countingapparatus include, for example, leukemia, aplastic anemia,myelodysplastic syndromes, paroxysmal nocturnal hemoglobinuria, systemiclupus erythematosus, malignant lymphoma, disseminated intravascularcoagulation, thrombotic thrombocytopenic purpura, hypersplenism,megaloblastic anemia, sepsis, tuberculosis, sarcoidosis, hemangioma,infectious diseases, and congenital thrombocytopenia.

Each of second determination ranges 360 is set as at least part ofcorresponding one of second erroneous ranges 373. Each of seconddetermination ranges 360 is set within a range satisfying correspondingone of first determination ranges 350 and within a range ofpredetermined erroneously low value.

In the example of FIG. 53 to FIG. 55, each of second determinationranges 360 is set within a range of erroneously low value (ALERT LOW) ofcorresponding one of second erroneous ranges 373 set for at least oneanalysis item of white blood cell count (WBC), hemoglobin concentration(HGB), hematocrit value (HCT), and platelet count (PLT). In FIG. 53 toFIG. 55, the range of erroneously low value (ALERT L) of each of whiteblood cell count, hemoglobin concentration, hematocrit value, andplatelet count is set as corresponding one of second determinationranges 360.

Thus, if numerical information 102 a is included in a range oferroneously low value (ALERT L), controller 140 prohibits the outputtingof numerical information 102 a. If there is numerical information 102 awithin second determination ranges 360, controller 140 causes outputunit 130 to output information 102 b indicating the type of theabnormality. To be more specific, if numerical information 102 a isincluded in a range of erroneously low value (ALERT L), controller 140prints information 315 indicating a second error (ALERT L) being anerroneously low value.

If numerical information 102 a is included in a range of erroneouslyhigh value (ALERT H), controller 140 permits the outputting of numericalinformation 102 a. If numerical information 102 a is included in a rangeof erroneously high value (ALERT H), controller 140 prints information315 indicating a second error being an erroneously high value (ALERT H).

For example, in the example of printed sheet 300 illustrated in FIG. 50,the value of HGB (24.3 [g/dL]) corresponds to an erroneously high valueof an adult, and “ALERT H” information 315 indicating a second error isprinted together with numerical information 102 a.

On the other hand, in the example of printed sheet 300 illustrated inFIG. 50, numerical information 102 a is not printed for WBC and PLT.This is because numerical information 102 a of WBC and PLT falls withinsecond determination ranges 360 (see FIG. 55). In the example of FIG.50, “ALERT L” information 315 indicating a second error is printed forthe analysis items of WBC and PLT. Thus, it is possible to know whichanalysis items fall within second determination ranges 360 even thoughnumerical information 102 a is not outputted.

When excluding a predetermined abnormal value from the content to beprinted, controller 140 causes substitute indication 313 to be printedin place of the predetermined abnormal value. For example, controller140 substitutes numerical information 102 a within second determinationranges 360 for substitute indication 313, and causes output unit 130 toprint substitute indication 313. In the example of FIG. 50, numericalinformation WBC and PLT within second determination ranges 360 isprinted in the form of substitute indication 313 “****.” Note that anydisplay embodiment of substitute indication 313 is possible as long asit can be distinguished from numerical information 102 a. Thus,substitute indication 313 is preferably a character other than a number,a symbol, or a plane figure, for example. If numerical information 102 ais within second determination ranges 360, controller 140 printsinformation 102 b indicating the type of the abnormality together withsubstitute indication 313.

As described above, if numerical information 102 a is included in firsterroneous ranges 372 or second erroneous ranges 373, controller 140outputs information 102 b indicating the type of the abnormality asanalysis results 102. Controller 140 prohibits the outputting ofnumerical information 102 a within second determination ranges 360, andpermits the outputting of information 102 b indicating the type of theabnormality.

On the other hand, if numerical information 102 a is outside firstdetermination ranges 350, controller 140 substitutes numericalinformation 102 a outside first determination ranges 350 for substituteindication 313 and causes output unit 130 to output substituteindication 313, and prohibits the outputting of information 102 bindicating the type of the abnormality. To be more specific, ifnumerical information 102 a falls within none of normal ranges 371,first erroneous ranges 372, and second erroneous ranges 373 describedabove, and is outside the linearity guarantee ranges, the numericalinformation is substituted for substitute indication 313 on printedsheet 300. Information 102 b indicating the type of the abnormality suchas information 314 or 315 is not printed.

In the example of FIG. 50, for the analysis items outside firstdetermination ranges 350 and for the analysis items within seconddetermination ranges 360, controller 140 prints the item names andprohibits the outputting of numerical information 102 a. When excludinga predetermined abnormal value from the content to be printed, printunit 135 prints substitute indication 313 in place of the predeterminedabnormal value.

Note that in the example of FIG. 51, the case where the outputting ofnumerical information 102 a is prohibited for the analysis items otherthan the measurement items includes the case of a fractionation error ofthe analysis results. In the case of a fractionation error, controller140 prohibits the outputting of numerical information 102 a, and outputsinformation 102 b indicating the type of the abnormality correspondingto the type of the fractionation error. Information 102 b indicating thetype of the abnormality corresponding to the type of the fractionationerror includes “WBC,” “RBC,” “PLT,” “WBC/PLT,” and “WBC Diff”. FIG. 50illustrates an example where WBC Diff is displayed, and “WBC,” “RBC,”“PLT,” and “WBC/PLT” are also displayed in the same manner.

“WBC” is printed if the number of particles of upper discriminator valueor lower discriminator value is erroneously high in the particle sizedistribution of white blood cells. The discriminator value is a valuefor distinguishing the distribution of white blood cells from noisecomponents called ghost. “RBC” is printed if the number of particles ofupper discriminator value or lower discriminator value is erroneouslyhigh in the particle size distribution of red blood cells, if it isimpossible to analyze red blood cell distribution width (RDW-SD andRDW-CV), or if the particle size distribution of red blood cells isbimodal. “PLT” is printed if the number of particles of upperdiscriminator value or lower discriminator value is erroneously high inthe particle size distribution of platelets, or if it is impossible toanalyze red blood cell distribution width (RDW-SD and RDW-CV). “WBC/PLT”is printed if the number of particles having a predetermined value orless is erroneously high in the particle size distribution of whiteblood cells. In the particle size distribution of white blood cells,“WBC Diff” is printed in any of the cases where it is impossible tofractionate into small-sized white blood cells and medium-sized whiteblood cells, where the discriminator value for fractionating intosmall-sized white blood cells and medium-sized white blood cells ishigh, where it is impossible to fractionate into medium-sized whiteblood cells and large-sized white blood cells, or where thediscriminator value for fractionating into medium-sized white bloodcells and large-sized white blood cells. In the cases of thesefractionation errors, controller 140 substitutes numerical information102 a for a substitute indication.

As illustrated in FIG. 50, for each of the analysis items, controller140 prohibits the outputting of numerical information 102 a outsidefirst determination ranges 350 and the outputting of numericalinformation 102 a within second determination ranges 360. For thisreason, in the case where numerical information 102 a outside thelinearity guarantee range is obtained or “ALERT L” numerical information102 a is obtained for any of the analysis items, other analysis itemsfor which printable numerical information 102 a is obtained are printed.

(Age Section)

FIG. 53 to FIG. 55 illustrate data examples of numerical ranges foranalysis result determination, for each of the age sections. As examplesof age sections, FIG. 53 illustrates an infant at the ages of two toeleven, FIG. 54 illustrates a youth at the ages of twelve to twenty, andFIG. 55 illustrates an adult at the ages of twenty one or more. Thenumber of sections may be other than three.

In the examples of FIG. 53 to FIG. 55, out of normal ranges 371, firsterroneous ranges 372, and second erroneous ranges 373, at least normalranges 371 differ depending on the age sections. Controller 140calculates the age of the subject from subject attribute information306, and obtains the numerical ranges of the age section correspondingto the calculated age. Then, when numerical information 102 a isobtained for each of the analysis items, analysis unit 120 analyzeswhich of normal ranges 371, first erroneous ranges 372, and seconderroneous ranges 373, and second determination ranges 360 numericalinformation 102 a falls within, based on the numerical ranges of the agesection to which the subject belongs.

In addition, controller 140 prints normal ranges 371 of the age sectionto which the subject belongs on printed sheet 300 as reference valueinformation 309. In the example of FIG. 49, it is possible to know fromsubject attribute information 306 (born in 1965) that the subject is anadult at the age of twenty one or more as of date information 303. Thus,FIG. 55 illustrates normal ranges 371 of the age section of an adultprinted as reference value information 309. Reference value information309 is printed for each of the analysis items. Here, in FIG. 53 to FIG.55, the numerical ranges of “ALERT L” second determination ranges 360are the same regardless of the age section. However, seconddetermination ranges 360 may be different for each age section.

(Predetermined Message)

Subsequently, the predetermined message printed on printed sheet 300 isdescribed. In the example of FIG. 49, if there is numerical information102 a within second determination ranges 360, controller 140 causesoutput unit 130 to output the predetermined message.

If numerical information 102 a is within second erroneous ranges 373,controller 140 prints message 311 prompting further testing. To be morespecific, if there is numerical information 102 a corresponding to anerroneously high value (ALERT H) or an erroneously low value (ALERT L)within second determination ranges 360 for any of the analysis items,message 311 prompting further testing is printed. In FIG. 49, as anexample, the message “RECOMMEND FURTHER TESTING” is printed.

Also, if numerical information 102 a is within second erroneous ranges373, controller 140 further prints message 312 recommending immediateaction. In FIG. 49, as an example, message 312 “Potential ALERT Valueshould be acted upon IMMEDIATELY” is printed.

Also, numerical information 102 a of all analysis items is within normalranges 371, controller 140 does not display message 311 and message 312.Controller 140 may display a message in message section 308 based ondisplay conditions for other messages. For example, regarding numericalinformation 102 a of three analysis items of WBC, RBC, and HGB, if thosethree items are not erroneously low values (ALERT L), but if all ofthose three items are low values (Low), controller 140 prints message311 prompting further testing but does not print message 312.

As described above, controller 140 controls the print content ofanalysis results 102. “END REPORT” printed on the end of printedinformation shows the end of printed sheet 300. Note that memory 142 ofcontroller 140 stores data necessary to output analysis results 102 suchas first determination ranges 350 and second determination ranges 360,information 102 b indicating the type of the abnormality, and message311 and message 312.

(Modified Example of Second Determination Range)

FIG. 53 to FIG. 55 illustrates an example where second determinationranges 360 are set to ranges of erroneously low value (ALERT L) withinsecond erroneous ranges 373. However, all of second erroneous ranges 373may be set to second determination ranges 360, for example. To be morespecific, second determination ranges 360 may be set also to ranges oferroneously high value (ALERT H), in addition to ranges of erroneouslylow value (ALERT L).

FIG. 56 illustrates a printing example where both erroneously low values(ALERT L) and an erroneously high value (ALERT H) are set as seconddetermination ranges 360. In the example of FIG. 50, numericalinformation 102 a is printed for the HGB item corresponding to anerroneously high value (ALERT H). In the example of FIG. 56, on theother hand, the outputting of numerical information 102 a is prohibitedfor the HGB item corresponding to an erroneously high value (ALERT H),and substitute indication 313 is printed instead of numericalinformation 102 a. In FIG. 56, numerical information 102 a correspondingto an item being an erroneously low value is substituted for substituteindication 313. “ALERT L” is assigned to an item of erroneously lowvalue as information 315 indicating a second error, and “ALERT H” isassigned to an item of erroneously high value (ALERT H) as information315 indicating a second error. Thus, it is possible to recognize whichof an erroneously low value and erroneously high value numericalinformation 102 a is even when the numerical information is not printed.

(Modified Example of Printing Embodiment)

The example of FIG. 50 and the example of FIG. 56 illustrate examples ofsubstituting numerical information 102 a falling within seconddetermination ranges 360 for substitute indication 313 and printing thesymbol. However, the configuration may be such that numericalinformation 102 a falling within second determination ranges 360 is notdisplayed, for example. The example of FIG. 57 illustrates an examplewhere numerical information 102 a falling within second determinationranges 360 is not displayed when both erroneously low values and anerroneously high value are set as second determination ranges 360. InFIG. 57, from the content to be printed, controller 140 excludesnumerical information 102 a falling within second determination ranges360 together with the item names of the analysis items. Thus,information 316 indicating that the numerical information falls withinsecond determination ranges 360 is not printed either. For this reason,in the example of FIG. 57, the analysis items themselves of WBC, HGB,and PLT with numerical information 102 a falling within seconddetermination ranges 360 have been excluded from result displayingsection 307.

On the other hand, also in the example of FIG. 57, if there is numericalinformation 102 a falling within second determination ranges 360,controller 140 prints message 311 prompting further testing in messagesection 308. In the example of FIG. 57, message 312 recommendingimmediate action is also printed. The user is allowed to recognize thereis an error in analysis results 102 by message 311 prompting furthertesting and message 312 recommending immediate action even in the casewhere numerical information 102 a falling within second determinationranges 360 is deleted together with the analysis items in resultdisplaying section 307.

(Modified Example of Output Rules for Analysis Result on Print Matter)

The example of FIG. 51 illustrates an example where in the initial test,controller 140 prohibits the outputting of print matter 300 if numericalinformation 102 a is included in first erroneous ranges 372, andperforms retest. However, print matter 300 may be outputted in theinitial test. In the initial test, if numerical information 102 a isincluded in first erroneous ranges 372, controller 140 may substitutenumerical information 102 a for substitute indication 313 and output thesymbol, or remove numerical information 102 a as a not-displayed itemfrom the print content together with the item names of the analysisitems.

FIG. 58 illustrates a modified example of output rules for analysisresults 102. In a first modification of FIG. 58, controller 140 permitsthe outputting of numerical information 102 a included in normal ranges371. Controller 140 prohibits the outputting of numerical information102 a outside first determination ranges 350, numerical information 102a within first erroneous ranges 372, numerical information 102 a withinsecond erroneous ranges 373, and numerical information 102 a in the caseof a fractionation error. Controller 140 substitutes numericalinformation 102 a for substitute indication 313 as in FIG. 56, where theoutputting of the numerical information is prohibited. In the firstmodification, controller 140 permits the outputting of information 102 bindicating the detail of the abnormality, out of analysis results 102.

In the case of a second modification of FIG. 58, controller 140 permitsthe outputting of numerical information 102 a included in normal ranges371. Controller 140 prohibits the outputting of numerical information102 a outside first determination ranges 350, numerical information 102a within first erroneous ranges 372, numerical information 102 a withinsecond erroneous ranges 373, and numerical information 102 a in the caseof a fractionation error. Controller 140 does not display numericalinformation 102 a on print matter 300, where the outputting of thenumerical information is prohibited. To be more specific, numericalinformation 102 a not within normal ranges 371 is not printed on printmatter 300 as in FIG. 57. In the second modification, controller 140also prohibits the outputting of information 102 b indicating the detailof the abnormality, out of analysis results 102. Thus, in the secondmodification, when an analysis item having numerical information 102 aoutside normal ranges 371 is obtained, all of its item name, numericalinformation 102 a, and information 102 b indicating the detail of theabnormality are removed from print matter 300, and the item itself isnot printed.

Additionally, the initial test and the retest are not distinguished inthe first modification and the second modification of FIG. 58. To bemore specific, in the initial test, if numerical information 102 a isincluded in first erroneous ranges 372, the outputting of numericalinformation 102 a is prohibited and print matter 300 is outputted.

(Error Display of Display Unit)

Subsequently, an error display of display unit 131 is described. Ifanalysis results 102 include an abnormal value, controller 140 causesprint unit 135 to print information 102 b indicating the detail of theabnormality as analysis results 102, and if there is an error with theapparatus other than with analysis results 102, the controller causesdisplay unit 131 to display information indicating there is an error.Analysis results 102 are outputted collectively on print matter 300, anddisplay unit 131 displays information other than on analysis results102. Information displayed by display unit 131 includes information oninstructions concerning the series of operations illustrated in FIG. 7to FIG. 48, and on an apparatus error.

To be more specific, display unit 131 displays information indicatingthere is an error if there is an error with the apparatus other thanwith analysis results 102. Thus, print unit 135 prints an error withanalysis results 102, and display unit 131 displays an apparatus error.An apparatus error is not printed by print unit 135, but is displayed bydisplay unit 131.

Display unit 131 displays information indicating there is an error forat least one of an error with analysis unit 120 and an error with aquality control process of analysis unit 120, for example. In analysisunit 120, when an error occurs in e.g. drive mechanism 122, fluidcircuit 124, or detector 123, controller 140 causes display unit 131 todisplay information 381 indicating there is an error as illustrated inFIG. 59. In addition, in the quality control process, for example,controller 140 causes display unit 131 to display information (screenP117) indicating there is an error illustrated in FIG. 30 when thequality control process fails such as when an analysis result of a QCreagent exceeds a reference range set for the QC reagent.

Note that the embodiments disclosed herein should be consideredillustrative and non-limited in all respects. The scope of the inventionis given by the scope of claims, not by the description of theembodiments described above, and moreover includes all modifications(modified examples) within the meaning and the scope equivalent to thescope of claims.

1-21. (canceled)
 22. A specimen analysis method comprising: displaying afirst screen through which subject attribute information of a specimento be measured is input; determining whether the subject attributeinformation is valid; performing a measurement of the specimen when thesubject attribute information is determined to be valid; selecting arange for analyzing a measurement result of the specimen at least from afirst range and a second range, the first range corresponding to thesubject attribute information of a first age group and the second rangecorresponding to the subject attribute information of a second agegroup; and outputting the measurement result being within the selectedrange while prohibiting the measurement result from being output whenthe measurement result is not within the selected range.
 23. The methodaccording to claim 22, wherein the subject attribute informationcomprises information on age.
 24. The method according to claim 23,wherein the information on age comprises at least one of an age, an agegroup, a birth year, and a birth date.
 25. The method according to claim22, further comprising displaying a second screen through which subjectidentification information of the specimen is input.
 26. The methodaccording to claim 22, further comprising prompting to re-input thesubject attribute information when the subject attribute information isdetermined to be invalid.
 27. The method according to claim 22, whereinthe outputting includes printing the measurement result on a paper. 28.The method according to claim 22, wherein the outputting includesadditionally printing a reference range on the paper.
 29. The methodaccording to claim 28, wherein the measurement result includes a firstmeasurement result of a first item and a second measurement result of asecond item, and the outputting includes printing the first measurementresult when the first measurement result is within the selected range,and the prohibiting includes masking the second measurement result onthe paper when the second measurement result is not within the selectedrange.
 30. The method according to claim 29, wherein the prohibitingfurther includes printing that the second measurement result iserroneously high or low.
 31. The method according to claim 22, whereinthe prohibiting includes prompting to re-test the specimen.
 32. Aspecimen analyzer comprising: an output unit comprising a display and aprinter; an input unit comprising one or more of: a touch panel, akeyboard, a mouse, and an identifier reader, which receives an input ofsubject identification information and subject attribute information; ananalysis unit comprising one or more detectors, which performs ameasurement of a specimen; and a controller programmed to performoperations comprising: causing the display to display a first screenthrough which subject attribute information of a specimen to be measuredis input; determining whether the subject attribute information isvalid; performing by the analysis unit a measurement of the specimenwhen the subject attribute information is determined to be valid;selecting a range for analyzing a measurement result of the specimen atleast from a first range and a second range, the first rangecorresponding to the subject attribute information of a first age groupand the second range corresponding to the subject attribute informationof a second age group; and outputting by the printer the measurementresult being within the selected range while prohibiting the measurementresult to be output when the measurement result is not within theselected range.
 33. The specimen analyzer according to claim 32, whereinthe subject attribute information comprises information on age.
 34. Thespecimen analyzer according to claim 33, wherein the information on agecomprises at least one of an age, an age group, a birth year, and abirth date.
 35. The specimen analyzer according to claim 32, wherein theoperations further comprise displaying a second screen through whichsubject identification information of the specimen is input.
 36. Thespecimen analyzer according to claim 32, wherein the operations furthercomprise prompting to re-input the subject attribute information whenthe subject attribute information is determined to be invalid.
 37. Thespecimen analyzer according to claim 32, wherein the outputting includesprinting the measurement result on a paper.
 38. The specimen analyzeraccording to claim 32, wherein the outputting includes additionallyprinting a reference range on the paper.
 39. The specimen analyzeraccording to claim 38, wherein the measurement result includes a firstmeasurement result of a first item and a second measurement result of asecond item, and the outputting includes printing the first measurementresult when the first measurement result is within the selected range,and the prohibiting includes masking the second measurement result onthe paper when the second measurement result is not within the selectedrange.
 40. The specimen analyzer according to claim 39, wherein theprohibiting further includes printing that the second measurement resultis erroneously high or low.
 41. The specimen analyzer according to claim32, wherein the prohibiting includes prompting to re-test the specimen.